Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-02-19 @ 12:01 AM
Study NCT ID:
NCT02571751
Status:
TERMINATED
Last Update Posted:
2021-09-28
First Post:
2015-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-label, Multi-center Trial to Evaluate Safety and Efficacy of Cohesive Silicone Gel-Filled Breast Implants UNIGEL®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-22', 'studyFirstSubmitDate': '2015-10-06', 'studyFirstSubmitQcDate': '2015-10-06', 'lastUpdatePostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'a rate of rupture of 4%', 'timeFrame': '2 years'}, {'measure': 'a rate of capsular contracture of 10%', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Kaplan-Meier Analysis of rupture or capsular contracture events', 'timeFrame': '2 years'}, {'measure': 'Change in nipple sensitivity', 'timeFrame': '2 years'}, {'measure': 'a rate of adverse evnets', 'timeFrame': '2 years'}, {'measure': 'Change in chest, bust and under bust circumference', 'timeFrame': '2 years'}, {'measure': 'SF-36(Short Form (36) Health Survey ), Evaluation of quality of life', 'timeFrame': '2 years'}]}, 'conditionsModule': {'conditions': ['Breast Augmentation']}, 'descriptionModule': {'briefSummary': 'Open-label, Multi-center, Clinical trial to Evaluate Safety and Efficacy of Cohesive Gel-Filled Breast Implants UNIGEL® Targeting of Women from 22 to 60 Aged with regard to Augmentation Mammaplasty for Purpose of Cosmetic Surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has given written informed consent to entry\n* Female, 22 years to 60 years\n* Breast augmentation(cosmetic surgery) is for following subjects\n\n * Who is not content with breast size and shape\n * Who has congenital asymmetrical deformity\n* subject who agree to MRI scan during the trial\n* subject who agree to visit to hospital according to schedule specified in the protocol during the entire period of the trial\n\nExclusion Criteria:\n\n* Pregnant or lactating women and women of childbearing age\n* Subject who has operation history of breast augmentation or reconstruction\n* Subject who has fibrocystic Breast Disease coming up for precancerous lesion not accompanied with subcutaneous mastectomy\n* Subject who has breast cancer or prodromal phase and no proper treatment.\n* Subject who is diagnosed with Breast Imaging-Reporting and Data System(BI-RADS) category 3 under breast ultrasonography.\n* Subject who has uncontrolled active infectious disease or abscess\n* Autoimmune disease\n* Diabetes mellitus\n* Keloidosis\n* Subject who cannot take general anesthesia due to abnormal blood or ECG results.\n* Subject who is not appropriate for breast augmentation due to damaged tissue or blood vessel or ulcer\n* Subject who has metal materials in a body such as ventricular assist system or cerebral aneurysm clips, or has claustrophobia (not suitable for MRI SCAN)\n* Physically/mentally disabled subject that may disturb understanding and cooperation for the trial.\n* Any other conditions that may interfere with correct assessment of the trial.'}, 'identificationModule': {'nctId': 'NCT02571751', 'briefTitle': 'Open-label, Multi-center Trial to Evaluate Safety and Efficacy of Cohesive Silicone Gel-Filled Breast Implants UNIGEL®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sewoon Medical Co., Ltd'}, 'orgStudyIdInfo': {'id': 'Protocol Approval No. 534'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breast Augmentation', 'interventionNames': ['Device: UNIGEL Silicone Gel-Filled Breast Implant']}], 'interventions': [{'name': 'UNIGEL Silicone Gel-Filled Breast Implant', 'type': 'DEVICE', 'armGroupLabels': ['Breast Augmentation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sewoon Medical Co., Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, {'name': 'Samsung Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}