Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT04743635
Status:
COMPLETED
Last Update Posted:
2023-06-06
First Post:
2021-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
CONtrolled Focal Fibrous Band Release Method Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071697', 'term': 'Cellulite'}], 'ancestors': [{'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rwalsh@revelleax.com', 'phone': '6509634498', 'title': 'Rachel Walsh, Senior Manager of Clinical Affairs', 'organization': 'Revelle Aesthetics, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.', 'eventGroups': [{'id': 'EG000', 'title': 'Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT', 'description': 'Modified intent to treat population (mITT), n=68. Cellulite can be treated across thighs and buttocks. Minimally invasive procedure: Procedure for reducing cellulite.', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 68, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in', 'description': 'Roll-in participants, n=6. Cellulite can be treated across thighs and buttocks. Minimally invasive procedure: Procedure for reducing cellulite.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 59, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Incision site bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fluid Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hemosiderin stain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tingling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperpigmentation', 'notes': 'Hyperpigementation of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Contact Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT', 'description': 'Allocation: N/A, Intervention Model: Single Group Assignment'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.0001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '1.28', 'ciUpperLimit': '1.71', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '.9', 'groupDescription': 'The endpoint tested the mean of the changes for each treated participant, not a 1-point change between mean score of the group at baseline versus 3 months. Success is achieved when the mean change across all treated participants is at least one point.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': "The 2-sided 95% confidence interval for the mean reduction in CSS was calculated along with the corresponding p-value (Student's t-test).", 'nonInferiorityComment': 'Performance goal.\n\nHypothesis:\n\nHo: D \\< 1 Ha: D ≥ 1, where D = reduction in the CSS score from baseline to 3 months, and 1 is the performance goal. If the lower bound of the two-sided 95% confidence interval is greater than or equal to 1 then we will reject the null hypothesis and conclude the device performs effectively.'}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The CSS includes a 6-point (range of 0-5) and will be determined by 3 independent, blinded physician assessors of images obtained before and 3-months after treatment.\n\nCSS Scale TOTAL CSS SCORE: = (PART A + PART B) - 1\n\nPART A- Number of evident depressions 0 None\n\n1. Mild (≤4 depressions)\n2. Moderate (5 to 9 depressions)\n3. Severe (≥ 10 depressions) PART B - Average depth of depressions\n\n0 None\n\n1. Mild (1-2 mm)\n2. Moderate (3-4 mm)\n3. Severe (≥5 mm)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT', 'description': 'Allocation: N/A, Intervention Model: Single Group Assignment'}], 'classes': [{'categories': [{'measurements': [{'value': '95.6', 'groupId': 'OG000', 'lowerLimit': '87.6', 'upperLimit': '99.1'}]}]}], 'analyses': [{'pValue': '.0001', 'groupIds': ['OG000'], 'paramType': 'Percentage improved', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '95.6', 'ciLowerLimit': '87.6', 'ciUpperLimit': '99.1', 'groupDescription': 'The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted (e.g., if "improved", "worse" and "much worse", "worse" was counted). A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Performance goal. The hierarchal endpoint is met if the lower bound of the 2-sided 95% confidence interval is greater than or equal to 0.6.'}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'The GAIS score was determined by blinded, independent evaluators. The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted. A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3). The hierarchal endpoint is met if the lower bound of the 2-sided 95% confidence interval is greater than or equal to 0.6.\n\nScale: -3:very much worse, the treated area appearance is worse than before procedure, -2: much worse, the treated area appearance is significantly worse than before procedure, -1: worsened, the treated area appearance is slightly worse than before procedure, 0:no change, the treated area appearance is the same, +1: improved, noticeable improvement in appearance of the treated areas, but subtle, +2: much improved, significant improvement in appearance in the treated areas, +3: very much improved, optimal cosmetic result in the treated areas.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT', 'description': 'Allocation: N/A, Intervention Model: Single Group Assignment'}], 'classes': [{'categories': [{'measurements': [{'value': '93.85', 'groupId': 'OG000', 'lowerLimit': '84.99', 'upperLimit': '98.30'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'The GAIS score was determined by blinded, independent evaluators. The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted. A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3).\n\nScale: -3: very much worse, the treated area appearance is worse than before procedure, -2: much worse, the treated area appearance is significantly worse than before procedure, -1: worsened, the treated area appearance is slightly worse than before procedure, 0:no change, the treated area appearance is the same, +1: improved, noticeable improvement in appearance of the treated areas, but subtle, +2: much improved, significant improvement in appearance in the treated areas, +3: very much improved, optimal cosmetic result in the treated areas.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'The Mean Change From Baseline to 12 Months in Cellulite Severity Scale (CSS) Score for Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT', 'description': 'Allocation: N/A, Intervention Model: Single Group Assignment'}], 'classes': [{'categories': [{'measurements': [{'value': '1.48', 'spread': '0.87', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The CSS includes a 6-point (range of 0-5) and will be determined by 3 independent, blinded physician assessors of images obtained before and 3-months after treatment.\n\nCSS Scale TOTAL CSS SCORE: = (PART A + PART B) - 1\n\nPART A- Number of evident depressions 0 None\n\n1. Mild (≤4 depressions)\n2. Moderate (5 to 9 depressions)\n3. Severe (≥ 10 depressions) PART B - Average depth of depressions\n\n0 None\n\n1. Mild (1-2 mm)\n2. Moderate (3-4 mm)\n3. Severe (≥5 mm)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}, {'type': 'SECONDARY', 'title': 'The Percentage of Patients Satisfied With Their Results at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT', 'description': 'Allocation: N/A, Intervention Model: Single Group Assignment'}], 'classes': [{'categories': [{'measurements': [{'value': '72.1', 'groupId': 'OG000', 'lowerLimit': '59.9', 'upperLimit': '82.3'}]}]}], 'analyses': [{'pValue': '.0264', 'groupIds': ['OG000'], 'paramType': 'Percentage improved', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '72.1', 'ciLowerLimit': '59.9', 'ciUpperLimit': '82.3', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Performance goal. In order to meet the endpoint, the lower bound of the 2-sided 95% confidence interval had to be greater than or equal to 0.6.'}], 'paramType': 'NUMBER', 'timeFrame': '3 month', 'description': 'Participants were asked to rate their satisfaction with their results (from very satisfied to very dissatisfied) in an online questionnaire at 3 months. The outcome measure reports the percentage of participants satisfied with their results at 3 months. The Site was blinded to the questionnaire data. The sponsor was only unblinded after the data analyses.\n\nThe lower bound of the 2-sided 95% confidence interval had to be greater than or equal to 0.6.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Patients Satisfied With Their Results at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT', 'description': 'Allocation: N/A, Intervention Model: Single Group Assignment'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Months', 'description': 'Participants were asked to rate their satisfaction with their results (from very satisfied to very dissatisfied) in an online questionnaire at 12 months. The outcome measure reports the number of participants satisfied with their results at 12 months. The Site was blinded to the questionnaire data. The sponsor was only unblinded after the data analyses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT', 'description': 'N=68, included in the effectiveness analyses Allocation: non-randomized Intervention Model: Single Group Assignment'}, {'id': 'FG001', 'title': 'Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in', 'description': 'N=6, excluded from the effectiveness analyses. The first two participants treated by three Investigators who never used the Avéli device were classified as roll-ins.\n\nAllocation: non-randomized Intervention model: Single group assignment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '74 was total enrollment:\n\n* 68 participants allocated to Targeted Verifiable Subcision (TVS) with the Avéli device, mITT\n* 6 participants allocated to Targeted Verifiable Subcision (TVS) with the Avéli device, Roll-Ins. 6 training participants for 3 new Investigators.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Targeted Verifiable Subcision (TVS) With the Avéli Device', 'description': 'Modified intent to treat population (mITT), n=68. Cellulite can be treated across thighs and buttocks. Minimally invasive procedure: Procedure for reducing cellulite.'}, {'id': 'BG001', 'title': 'Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in', 'description': 'Roll-in participants, n=6. Cellulite can be treated across thighs and buttocks. Minimally invasive procedure: Procedure for reducing cellulite.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '40.8', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '41.5', 'spread': '7.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Fitzpatrick Skin Type', 'classes': [{'categories': [{'title': 'I', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'II', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'III', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'IV', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'V', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'VI', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Used by site to evaluate the participant's skin type using the following scale:\n\nType 1: light, pale white Type 2: white, fair Type 3: medium white to olive Type 4: olive, moderate brown Type 5: brown, dark brown Type 6: black, very dark, brown to black", 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '24.9', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '23.1', 'spread': '3.6', 'groupId': 'BG001'}, {'value': '24.8', 'spread': '2.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Laxity', 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Mild', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Moderate', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-29', 'size': 1148566, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-11T14:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants were treated with the Avéli device.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2021-02-03', 'resultsFirstSubmitDate': '2022-06-13', 'studyFirstSubmitQcDate': '2021-02-03', 'lastUpdatePostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-10', 'studyFirstPostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants', 'timeFrame': '3 months', 'description': 'The CSS includes a 6-point (range of 0-5) and will be determined by 3 independent, blinded physician assessors of images obtained before and 3-months after treatment.\n\nCSS Scale TOTAL CSS SCORE: = (PART A + PART B) - 1\n\nPART A- Number of evident depressions 0 None\n\n1. Mild (≤4 depressions)\n2. Moderate (5 to 9 depressions)\n3. Severe (≥ 10 depressions) PART B - Average depth of depressions\n\n0 None\n\n1. Mild (1-2 mm)\n2. Moderate (3-4 mm)\n3. Severe (≥5 mm)'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months', 'timeFrame': '3 months', 'description': 'The GAIS score was determined by blinded, independent evaluators. The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted. A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3). The hierarchal endpoint is met if the lower bound of the 2-sided 95% confidence interval is greater than or equal to 0.6.\n\nScale: -3:very much worse, the treated area appearance is worse than before procedure, -2: much worse, the treated area appearance is significantly worse than before procedure, -1: worsened, the treated area appearance is slightly worse than before procedure, 0:no change, the treated area appearance is the same, +1: improved, noticeable improvement in appearance of the treated areas, but subtle, +2: much improved, significant improvement in appearance in the treated areas, +3: very much improved, optimal cosmetic result in the treated areas.'}, {'measure': 'Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 Months', 'timeFrame': '12 Months', 'description': 'The GAIS score was determined by blinded, independent evaluators. The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted. A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3).\n\nScale: -3: very much worse, the treated area appearance is worse than before procedure, -2: much worse, the treated area appearance is significantly worse than before procedure, -1: worsened, the treated area appearance is slightly worse than before procedure, 0:no change, the treated area appearance is the same, +1: improved, noticeable improvement in appearance of the treated areas, but subtle, +2: much improved, significant improvement in appearance in the treated areas, +3: very much improved, optimal cosmetic result in the treated areas.'}, {'measure': 'The Mean Change From Baseline to 12 Months in Cellulite Severity Scale (CSS) Score for Participants', 'timeFrame': '12 months', 'description': 'The CSS includes a 6-point (range of 0-5) and will be determined by 3 independent, blinded physician assessors of images obtained before and 3-months after treatment.\n\nCSS Scale TOTAL CSS SCORE: = (PART A + PART B) - 1\n\nPART A- Number of evident depressions 0 None\n\n1. Mild (≤4 depressions)\n2. Moderate (5 to 9 depressions)\n3. Severe (≥ 10 depressions) PART B - Average depth of depressions\n\n0 None\n\n1. Mild (1-2 mm)\n2. Moderate (3-4 mm)\n3. Severe (≥5 mm)'}, {'measure': 'The Percentage of Patients Satisfied With Their Results at 3 Months', 'timeFrame': '3 month', 'description': 'Participants were asked to rate their satisfaction with their results (from very satisfied to very dissatisfied) in an online questionnaire at 3 months. The outcome measure reports the percentage of participants satisfied with their results at 3 months. The Site was blinded to the questionnaire data. The sponsor was only unblinded after the data analyses.\n\nThe lower bound of the 2-sided 95% confidence interval had to be greater than or equal to 0.6.'}, {'measure': 'The Number of Patients Satisfied With Their Results at 12 Months', 'timeFrame': '12 Months', 'description': 'Participants were asked to rate their satisfaction with their results (from very satisfied to very dissatisfied) in an online questionnaire at 12 months. The outcome measure reports the number of participants satisfied with their results at 12 months. The Site was blinded to the questionnaire data. The sponsor was only unblinded after the data analyses.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cellulite']}, 'descriptionModule': {'briefSummary': 'Study to evaluate the safety and effectiveness of the Avéli medical device to reduce the appearance of cellulite.', 'detailedDescription': 'Multi-center, single-arm clinical study to evaluate the safety and effectiveness of the Avéli device in reducing the appearance of cellulite.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe cellulite\n\nExclusion Criteria:\n\n* Body Mass Index ≥30.0'}, 'identificationModule': {'nctId': 'NCT04743635', 'acronym': 'CONFFIRM', 'briefTitle': 'CONtrolled Focal Fibrous Band Release Method Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Revelle Aesthetics, Inc'}, 'officialTitle': 'CONtrolled Focal Fibrous Band Release Method Study', 'orgStudyIdInfo': {'id': 'CP-10472'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Targeted Verifiable Subcision (TVS) with the Avéli device, mITT', 'description': 'Modified intent to treat population (n=68). The modified intent to treat population was used to evaluate effectiveness.\n\nThe single procedure was conducted using the Avéli device for TVS. Cellulite can be treated on the thighs and buttocks', 'interventionNames': ['Device: Avéli device']}, {'type': 'EXPERIMENTAL', 'label': 'Targeted Verifiable Subcision (TVS) with the Avéli device, Roll-in', 'description': 'The roll-in population (n=6) was excluded from the effectiveness analyses. For Investigators that have not previously performed an Avéli procedure, two (2) participants were classified as roll-in participants. The single procedure was conducted using the Avéli device for TVS. Cellulite can be treated on the thighs and buttocks', 'interventionNames': ['Device: Avéli device']}], 'interventions': [{'name': 'Avéli device', 'type': 'DEVICE', 'description': 'Minimally invasive single procedure with the Avéli device for reduction in the appearance of cellulite in the thighs and buttocks.', 'armGroupLabels': ['Targeted Verifiable Subcision (TVS) with the Avéli device, Roll-in', 'Targeted Verifiable Subcision (TVS) with the Avéli device, mITT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90292', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site #3', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site #5', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94102', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site #4', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Site #2', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '71105', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Clinical Site #6', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '02467', 'city': 'Chestnut Hill', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Clinical Site #8', 'geoPoint': {'lat': 42.33065, 'lon': -71.16616}}, {'zip': '55441', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Clinical Site #1', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Clinical Site #7', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '4350', 'city': 'Toowoomba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Clinical Site #9', 'geoPoint': {'lat': -27.56056, 'lon': 151.95386}}], 'overallOfficials': [{'name': 'Dr. G. William Stevens, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marina Plastic Surgery'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Will post Protocol Executive Summary on June 14, 2022. It will be available indefinitely.', 'ipdSharing': 'YES', 'description': 'Plan to share Executive Summary of Protocol. No formal, separate SAP for this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Revelle Aesthetics, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}