Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-30 @ 3:07 PM
Study NCT ID:
NCT05665335
Status:
COMPLETED
Last Update Posted:
2025-05-14
First Post:
2022-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Post-Market Study in Greece of a Minimally Invasive Breast Lift Procedure Utilizing the Renuvion APR System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kari.larson@apyxmedical.com', 'phone': '8012440058', 'title': 'Kari Larson, Sr. Director of Clinical Affairs', 'organization': 'Apyx Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events and expected treatment effects were evaluated over the 180-day follow-up period.', 'description': 'Adverse events and expected treatment effects (ETEs) were collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Independent Photographic Review of Before and After Images Compared to Baseline Compared to D180.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180-Day', 'description': 'Improvement in breast ptosis as determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline by blinded independent reviewers.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Independent Photographic Review of Before and After Images Compared to Baseline at D90.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90-Day', 'description': 'Improvement in breast ptosis as determined by a masked, qualitative assessment of photographs at 90-days post-treatment compared to baseline by blinded independent reviewers.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Morphometric Breast Measurements at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'classes': [{'title': 'SNN-N: Suprasternal notch to nipple distance', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'IMC-N: Inframammary crease to nipple distance', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'MCL-N: Midclavicular line to nipple distance', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'NAC: nipple-areola complex diameter', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'PROJ: maximum point of breast projection measured perpendicular to the chest wall', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'N-N: nipple to nipple distance', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'SSN-IMC: vertical distance from the suprasternal notch to the inframammary crease', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'SSN-base: vertical distance from the suprasternal notch to the lowest point on the base', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30-Day', 'description': 'Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D30.', 'unitOfMeasure': 'cm change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Morphometric Breast Measurements at Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'classes': [{'title': 'SNN-N: measurements taken at the mid nipple diameter on both sides', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'IMC-N: measurement taken from the base of the breast to the base of the nipple', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'MCL-N: measurement taken from the mid clavicle to the mid nipple', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'NAC: nipple-areola complex diameter', 'categories': [{'measurements': [{'value': '-01.', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'PROJ: maximum point of breast projection measured perpendicular to the chest wall', 'categories': [{'measurements': [{'value': '0', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'N-N: measurements taken at the mid nipple diameter on both sides', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'SSN-IMC: vertical distance from the suprasternal notch to the inframammary crease', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'SSN-base: vertical distance from the suprasternal notch to the lowest point on the base', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90-Day', 'description': 'Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D90.', 'unitOfMeasure': 'cm change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Morphometric Breast Measurements at Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'classes': [{'title': 'SNN-N: measurements taken at the mid nipple diameter on both sides', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'IMC-N: measurement taken from the base of the breast to the base of the nipple', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'MCL-N: measurement taken from the mid clavicle to the mid nipple', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'NAC: nipple-areola complex diameter', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'PROJ: maximum point of breast projection measured perpendicular to the chest wall', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'N-N: measurements taken at the mid nipple diameter on both sides', 'categories': [{'measurements': [{'value': '0', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'SSN-IMC: vertical distance from the suprasternal notch to the inframammary crease', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'SSN-base: vertical distance from the suprasternal notch to the lowest point on the base', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180-Day', 'description': 'Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D180.', 'unitOfMeasure': 'cm change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Breast Ptosis Classification at Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'classes': [{'categories': [{'title': 'Grade I', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Grade II', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Grade III', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade IV', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Grade V', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180-Day', 'description': 'Evaluation by the investigator grading the amount of visual breast ptosis (breast laxity) by the Rainbow scale of ptosis includes 5 grades: a Grade I (no ptosis), Grade II (minimal ptosis), Grade III (moderate ptosis), Grade IV (more than moderate ptosis), V (severe ptosis) scale.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'classes': [{'categories': [{'title': 'Very Much Improved', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Much Improved', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Much Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very Much Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30-Day', 'description': 'The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'classes': [{'categories': [{'title': 'Very Much Improved', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Much Improved', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Much Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very Much Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90-Day', 'description': 'The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'classes': [{'categories': [{'title': 'Very Much Improved', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Much Improved', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Much Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very Much Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180-Day', 'description': 'The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subject Global Aesthetic Improvement Scale (GAIS) at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'classes': [{'categories': [{'title': 'Very Much Improved', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Much Improved', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Much Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very Much Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30-Day', 'description': 'The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subject Global Aesthetic Improvement Scale (GAIS) at Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'classes': [{'categories': [{'title': 'Very Much Improved', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Much Improved', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Much Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very Much Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90-Day', 'description': 'The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Subject Global Aesthetic Improvement Scale (GAIS) at Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'classes': [{'categories': [{'title': 'Very Much Improved', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Much Improved', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Improved', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Much Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Very Much Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180-Day', 'description': 'The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Satisfaction Questionnaire (PSQ) at Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'classes': [{'title': 'Yes, Improvement Noticed in Breast Area', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Yes, Less Sagging Breasts', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Yes, Breasts Look Higher on Chest', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Yes, Nipple Placement is Improved', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Yes, Breasts Appear More Youthful', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Yes, Would recommend to friends and family', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '180-Day', 'description': 'Subjects will be asked to complete a satisfaction survey referring to the assessment of baseline photos, current photos, and a mirror. Yes/No - Did you notice any improvement in the laxity or sagginess of your breasts? If yes, checkbox - Less sagging, Breasts look higher on the chest, Nipple placement is improved, Breasts appear more youthful, and/or Other. How would you characterize your satisfaction with the treatment? - very satisfied, satisfied, slightly satisfied, neither satisfied or dissatisfied, slightly dissatisfied, dissatisfied, very dissatisfied. Yes/No - Would you recommend this treatment to your friends and family members?', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Breast-Q Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'classes': [{'title': 'Confident in a social setting?', 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Good about yourself?', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Confident in your clothes?', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Of equal worth to other women?', 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Attractive?', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Accepting of your body?', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Self-assured?', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Confident about your body?', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Self-confident?', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Sexually attractive in your clothes?', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Comfortable/at ease during sexual activity?', 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Confident sexually?', 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Sexy when unclothed?', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Confident sexually about how your breasts look when unclothed?', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180-Day', 'description': 'Subjects will complete the Psychosocial Well-Being and Sexual Well-Being questionnaires. Subjects were instructed "With your breasts in mind, in the past week, how often have you felt:". Responses were 5 options: 1 - None of the time, 2 - A little of the time, 3 - Some of the time, 4 - Most of the time, 5 - All of the time.', 'unitOfMeasure': 'average units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Average Reported by Subject at Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '6', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '7', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '8', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '9', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '10', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Procedure Day 0 (within 60 minutes following treatment)', 'description': 'Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Average Reported Pain by Subject at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '6', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '7', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '8', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '9', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '10', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30-Day', 'description': 'Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Average Reported Pain by Subject at Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '6', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '7', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '8', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '9', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '10', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90-Day', 'description': 'Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Average Reported Pain by Subject at Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '6', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '7', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '8', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '9', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '10', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180-Day', 'description': 'Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.\n\nRenuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38', 'spread': '9.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Nationality', 'categories': [{'title': 'Greek', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Albanian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Brazilian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Greece', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Breast Cup Size', 'classes': [{'categories': [{'title': 'Cup Size A', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Cup Size B', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Hemicircumference measured across the maximum projection of the breast from the medial inflection point to the lateral inflection point where the breast creates a crease in the skin when the breast is displaced or pushed medially or laterally. A Cup = 17.0 cm. B Cup = 19.5 cm. C Cup = 21.5 cm. D Cup = 23.5 cm. DD Cup = 25.0 cm.', 'unitOfMeasure': 'Participants'}, {'title': 'ASA Status', 'classes': [{'categories': [{'title': 'ASA I', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'ASA II', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Evaluation by the investigator determining patient health by the American Society of Anesthesiologists Scale:\n\nASA I = A normal healthy patient ASA II = A patient with mild systemic disease ASA III = A patient with severe systemic disease ASA IV = A patient with severe systemic disease that is a constant threat to life ASA V = A moribund patient who is not expected to survive without the operation ASA VI = A declared brain-dead patient whose organs are being removed for donor purposes.', 'unitOfMeasure': 'Participants'}, {'title': 'Rainbow Scale for Breast Ptosis', 'classes': [{'categories': [{'title': 'Grade I', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Grade II', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Grade III', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Grade IV', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Grade V', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Evaluation by the investigator grading the amount of visual breast ptosis (breast laxity) by the Rainbow scale of ptosis includes 5 grades: a Grade I (no ptosis), Grade II (minimal ptosis), Grade III (moderate ptosis), Grade IV (more than moderate ptosis), V (severe ptosis) scale.', 'unitOfMeasure': 'Participants'}, {'title': 'Breast-Q Survey', 'classes': [{'title': 'Confident in a social setting?', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.9', 'groupId': 'BG000'}]}]}, {'title': 'Good about yourself?', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.7', 'groupId': 'BG000'}]}]}, {'title': 'Confident in your clothes?', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.6', 'groupId': 'BG000'}]}]}, {'title': 'Of equal worth to other women?', 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.9', 'groupId': 'BG000'}]}]}, {'title': 'Attractive?', 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.7', 'groupId': 'BG000'}]}]}, {'title': 'Accepting of your body?', 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.8', 'groupId': 'BG000'}]}]}, {'title': 'Self-assured?', 'categories': [{'measurements': [{'value': '3.7', 'spread': '0.6', 'groupId': 'BG000'}]}]}, {'title': 'Confident about your body?', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.5', 'groupId': 'BG000'}]}]}, {'title': 'Self-confident?', 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.4', 'groupId': 'BG000'}]}]}, {'title': 'Sexually attractive in your clothes?', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.7', 'groupId': 'BG000'}]}]}, {'title': 'Comfortable/at ease during sexual activity?', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.8', 'groupId': 'BG000'}]}]}, {'title': 'Confident sexually?', 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.7', 'groupId': 'BG000'}]}]}, {'title': 'Sexy when unclothed?', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.6', 'groupId': 'BG000'}]}]}, {'title': 'Confident sexually about how your breasts look when unclothed?', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Subjects will complete the Psychosocial Well-Being and Sexual Well-Being questionnaires. Subjects were instructed "With your breasts in mind, in the past week, how often have you felt:". Responses were 5 options: 1 - None of the time, 2 - A little of the time, 3 - Some of the time, 4 - Most of the time, 5 - All of the time.', 'unitOfMeasure': 'Average units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Average Reported Pain by Subject', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': '1', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '6', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '7', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '8', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '9', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '10', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain".', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-23', 'size': 1236763, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-24T15:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2022-12-16', 'resultsFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2022-12-16', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-29', 'studyFirstPostDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Morphometric Breast Measurements at Day 30', 'timeFrame': '30-Day', 'description': 'Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D30.'}, {'measure': 'Change in Morphometric Breast Measurements at Day 90', 'timeFrame': '90-Day', 'description': 'Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D90.'}, {'measure': 'Change in Morphometric Breast Measurements at Day 180', 'timeFrame': '180-Day', 'description': 'Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D180.'}, {'measure': 'Change in Breast Ptosis Classification at Day 180', 'timeFrame': '180-Day', 'description': 'Evaluation by the investigator grading the amount of visual breast ptosis (breast laxity) by the Rainbow scale of ptosis includes 5 grades: a Grade I (no ptosis), Grade II (minimal ptosis), Grade III (moderate ptosis), Grade IV (more than moderate ptosis), V (severe ptosis) scale.'}, {'measure': 'Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30', 'timeFrame': '30-Day', 'description': 'The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.'}, {'measure': 'Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90', 'timeFrame': '90-Day', 'description': 'The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.'}, {'measure': 'Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180', 'timeFrame': '180-Day', 'description': 'The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.'}, {'measure': 'Subject Global Aesthetic Improvement Scale (GAIS) at Day 30', 'timeFrame': '30-Day', 'description': 'The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.'}, {'measure': 'Subject Global Aesthetic Improvement Scale (GAIS) at Day 90', 'timeFrame': '90-Day', 'description': 'The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.'}, {'measure': 'Subject Global Aesthetic Improvement Scale (GAIS) at Day 180', 'timeFrame': '180-Day', 'description': 'The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.'}, {'measure': 'Patient Satisfaction Questionnaire (PSQ) at Day 180', 'timeFrame': '180-Day', 'description': 'Subjects will be asked to complete a satisfaction survey referring to the assessment of baseline photos, current photos, and a mirror. Yes/No - Did you notice any improvement in the laxity or sagginess of your breasts? If yes, checkbox - Less sagging, Breasts look higher on the chest, Nipple placement is improved, Breasts appear more youthful, and/or Other. How would you characterize your satisfaction with the treatment? - very satisfied, satisfied, slightly satisfied, neither satisfied or dissatisfied, slightly dissatisfied, dissatisfied, very dissatisfied. Yes/No - Would you recommend this treatment to your friends and family members?'}, {'measure': 'Breast-Q Survey', 'timeFrame': '180-Day', 'description': 'Subjects will complete the Psychosocial Well-Being and Sexual Well-Being questionnaires. Subjects were instructed "With your breasts in mind, in the past week, how often have you felt:". Responses were 5 options: 1 - None of the time, 2 - A little of the time, 3 - Some of the time, 4 - Most of the time, 5 - All of the time.'}, {'measure': 'Average Reported by Subject at Procedure', 'timeFrame': 'Procedure Day 0 (within 60 minutes following treatment)', 'description': 'Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"'}, {'measure': 'Average Reported Pain by Subject at Day 30', 'timeFrame': '30-Day', 'description': 'Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"'}, {'measure': 'Average Reported Pain by Subject at Day 90', 'timeFrame': '90-Day', 'description': 'Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"'}, {'measure': 'Average Reported Pain by Subject at Day 180', 'timeFrame': '180-Day', 'description': 'Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"'}], 'primaryOutcomes': [{'measure': 'Independent Photographic Review of Before and After Images Compared to Baseline Compared to D180.', 'timeFrame': '180-Day', 'description': 'Improvement in breast ptosis as determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline by blinded independent reviewers.'}], 'secondaryOutcomes': [{'measure': 'Independent Photographic Review of Before and After Images Compared to Baseline at D90.', 'timeFrame': '90-Day', 'description': 'Improvement in breast ptosis as determined by a masked, qualitative assessment of photographs at 90-days post-treatment compared to baseline by blinded independent reviewers.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Ptosis']}, 'referencesModule': {'references': [{'pmid': '40236884', 'type': 'RESULT', 'citation': 'Sterodimas A, Moutafis A, Nicaretta B, Champsas G. A Prospective Study on Helium-Based Plasma Radiofrequency for Minimally Invasive Breast Lift Scarless Mastopexy. Aesthet Surg J Open Forum. 2025 Mar 5;7:ojaf004. doi: 10.1093/asjof/ojaf004. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, non-randomized, single-center, evaluator blinded study of up to 15 subjects undergoing a minimally invasive breast lift procedure utilizing the Renuvion APR System. Subjects will receive treatment with the Renuvion APR System to both breasts.', 'detailedDescription': "This is a prospective, non-randomized, single-center, evaluator blinded study of up to 15 subjects undergoing a minimally invasive breast lift procedure utilizing the Renuvion APR System. Subjects will receive treatment with the Renuvion APR System to both breasts.\n\nAt baseline, the grade of breast ptosis, breast measurements and pre-surgery photographs will be taken using the site's camera system.\n\nProcedure data and adverse events will be captured.\n\nFollow-up visits will occur at 30, 90, and 180-days post-procedure. Subjects may also be seen back for follow-up at the investigator's discretion."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female subjects', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female subjects, ages 18 - 75 years old.\n* ASA Physical Status Classification System Class I and Class II subjects.\n* Breast Ptosis Class II and Class III as per the Eyck et al, Rainbow Scale for Assessing Breast Ptosis.\n* Breast Cup Size A and Size B.\n* Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation.\n* Absence of physical conditions unacceptable to the investigator.\n* Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.\n* Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits.\n* Willing to release rights for the use of study photos, including in publication.\n* Able to read, understand, sign, and date the informed consent.\n* Able to communicate with the site via video and/or photographs, in the event of a virtual follow-up visit.\n\nExclusion Criteria:\n\n* Subjects presenting with ASA Physical Status Classification System Classes III or higher.\n* Breast ptosis Class IV or more as per the Eyck et al, Rainbow Scale for Assessing Breast Ptosis.\n* Breast Cup Size C, Size D or larger.\n* Prior surgery or procedure in the breast area (i.e., implants, skin tightening procedures, breast reduction, etc.).\n* Pregnant, lactating, or plans to become pregnant during study participation.\n* Known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine).\n* Known hypersensitivity or allergy to ibuprofen or other NSAIDS.\n* Previous treatment in the study treatment area.\n* Active systemic or local skin disease that may alter wound healing.\n* Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health.\n* History of autoimmune disease (excluding Hashimoto's thyroiditis).\n* Known susceptibility to keloid formation or hypertrophic scarring.\n* Cancerous or pre-cancerous lesions in the area to be treated.\n* Possesses a surgically implanted electronic device (i.e., pacemaker).\n* Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.\n* Participation in any other investigational study within 30 days prior to consent and throughout study participation.\n* Subject who, in the opinion of the investigator, is not an appropriate candidate for the study."}, 'identificationModule': {'nctId': 'NCT05665335', 'briefTitle': 'A Post-Market Study in Greece of a Minimally Invasive Breast Lift Procedure Utilizing the Renuvion APR System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apyx Medical'}, 'officialTitle': 'A Post-Market Study of a Minimally Invasive Beast Lift Procedure Utilizing the Renuvion APR System', 'orgStudyIdInfo': {'id': 'APX-22-03-GR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Renuvion APR System', 'description': 'Subjects treated with the Renuvion APR system in both breasts.', 'interventionNames': ['Device: Renuvion APR System']}], 'interventions': [{'name': 'Renuvion APR System', 'type': 'DEVICE', 'description': 'The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.\n\nRenuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.', 'armGroupLabels': ['Renuvion APR System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15562', 'city': 'Athens', 'country': 'Greece', 'facility': 'Metropolitan General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Aris Sterodimas, MD, MSc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Metropolitan General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apyx Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}