Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2026-01-29 @ 3:02 PM
Study NCT ID:
NCT04185961
Status:
COMPLETED
Last Update Posted:
2020-05-20
First Post:
2019-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study to Determine the Optimal Negative Pressure for Non-invasive Breast Augmentation in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'A Double-blind Pilot Study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'EVERA-RAPHA with 60 mmHg: EVERA-RAPHA apply 15 minutes with 60mmHG every day for 4 weeks EVERA-RAPHA with 100 mmHg: EVERA-RAPHA apply 15 minutes with 100mmHG every day for 4 weeks'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-19', 'studyFirstSubmitDate': '2019-12-01', 'studyFirstSubmitQcDate': '2019-12-01', 'lastUpdatePostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in the breast volume between before and after 4 weeks in test group 1 and test group 2 respectively.', 'timeFrame': 'Baseline and after 4 weeks', 'description': 'change in the breast volume between before and after 4 weeks of wearing the medical device in test group 1 and test group 2 respectively.'}], 'secondaryOutcomes': [{'measure': 'change in the breast circumference between before and after 4 weeks in test group 1 and test group 2 respectively.', 'timeFrame': 'Baseline and after 4 weeks', 'description': 'change in the breast circumference between before and after 4 weeks of wearing the medical device in test group 1 and test group 2 respectively.'}, {'measure': 'difference the mean breast volume between test group 1 and test group 2', 'timeFrame': 'Baseline and after 4 weeks', 'description': 'difference the mean breast volume between test group 1 and test group 2'}, {'measure': 'difference the mean breast circumference between test group 1 and test group 2', 'timeFrame': 'Baseline and after 4 weeks', 'description': 'difference the mean breast circumference between test group 1 and test group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Hypoplasia']}, 'descriptionModule': {'briefSummary': 'Aim is to investigate optimum pressure and evaluate safety and effectiveness of EVERA-RAPHA for breast augmentation', 'detailedDescription': '1. Subjects who voluntarily signed a consent form and met all inclusion / exclusion criteria should enroll in this study.\n2. Subjects enrolled in the study will be randomized and assigned to either Group1 or Group2 in a 1: 1 ratio.\n3. Apply EVERA RAPHA for 4 weeks\n\n3\\. Measure breast circumference and breast volume at Baseline and 4weeks later 4. Visit after 4 weeks to evaluate safety and effectiveness'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A woman over the age of twenty\n2. A woman who wants both breast enlargement\n3. A person whose difference between chest circumference and lower chest circumference is less than 10 cm.\n4. Subject who sign the consent form of the study and agree to participate in the clinical trial\n5. Subject who are willing and able to comply with study protocol\n\nExclusion Criteria:\n\n1. A woman who has a history of great weight-change\n2. A case that Breast cancer or mammary tumour found in basic physical examinations\n3. A woman with symptoms or history that suggest she has a fibroblastoma, breast pain, periodic congestion, etc.\n4. A woman with severe trauma around the breast.\n5. A woman with a scar or skin lesion around the breast.\n6. A woman with more than breast ptosis of Grade 3 (the nipple is less than 1-3 cm below the breast)\n7. A woman with a history of chronic dermatitis, chronic pressure urticaria, contact dermatitis, etc.\n8. A woman who disagrees with contraception\n9. A woman who has previously undergone a breast reconstruction or breast augmentation\n10. A woman with an uncontrolled active infectious disease'}, 'identificationModule': {'nctId': 'NCT04185961', 'briefTitle': 'Pilot Study to Determine the Optimal Negative Pressure for Non-invasive Breast Augmentation in Women', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Double-blind Pilot Study to Determine the Optimal Negative Pressure of EVERA-RAPHA for Non-invasive Breast Augmentation in Women', 'orgStudyIdInfo': {'id': 'GNSD_EVRP_2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EVERA-RAPHA with 60mmHG', 'description': 'EVERA-RAPHA apply 15 minutes with 60mmHG every day for 4 weeks', 'interventionNames': ['Device: EVERA-RAPHA with 60mmHG']}, {'type': 'EXPERIMENTAL', 'label': 'EVERA-RAPHA with 100mmHG', 'description': 'EVERA-RAPHA apply 15 minutes with 100mmHG every day for 4 weeks', 'interventionNames': ['Device: EVERA-RAPHA with 100mmHG']}], 'interventions': [{'name': 'EVERA-RAPHA with 60mmHG', 'type': 'DEVICE', 'description': 'Apply EVERA-RAPHA with 60mmHG for 4weeks', 'armGroupLabels': ['EVERA-RAPHA with 60mmHG']}, {'name': 'EVERA-RAPHA with 100mmHG', 'type': 'DEVICE', 'description': 'Apply EVERA-RAPHA with 100mmHG for 4weeks', 'armGroupLabels': ['EVERA-RAPHA with 100mmHG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Bundang,Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National Univ. Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Chan Yeong Heo, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}