Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-02 @ 5:17 PM
Study NCT ID:
NCT06510205
Status:
RECRUITING
Last Update Posted:
2025-10-10
First Post:
2024-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study is an Oberservational Post-market Follow-up Program to Evaluate Long Term(5 Years) Safety of Mentor Breast Implants in Chinese Population.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2034-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-09', 'studyFirstSubmitDate': '2024-07-05', 'studyFirstSubmitQcDate': '2024-07-18', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breast implant related AEs', 'timeFrame': 'Up to 5 years', 'description': 'Post-op 1 month, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years'}], 'secondaryOutcomes': [{'measure': 'Numerical Pain Scale assessment', 'timeFrame': '1 month after surgery', 'description': 'Zero means you have no pain, while 10 represents the most intense pain possible.'}, {'measure': 'Customer Satisfaction Score measurement', 'timeFrame': 'Up to 5 years after surgery', 'description': 'Measured at 1 month, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years after surgery Using a 5-point scoring scale, 5 means very satisfied while 1 means very disatisfied.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Augmentation and Breast Reconstruction']}, 'descriptionModule': {'briefSummary': "The Mentor Post-Market Clinical Follow-Up Study is a multicenter observational study conducted in China. It aims to collect safety data on Mentor breast implants over a 5-year follow-up period in the Chinese population. In addition to safety data, the study will also gather information on postoperative pain and participant satisfaction levels. The objective is to explore customers' clinical experiences and use them as a reference for future product development. The study intends to enroll a minimum of 300 subjects per license, with participation from three or more medical institutions."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '22 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All populations receiving Mentor breast implants', 'genderDescription': 'Per product instruction for use(IFU)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women who have received Mentor breast implants per product instructions;\n2. Participants must possess the ability to comprehend the study procedures, give consent for the use of their preoperative and surgical data, and agree to take part in postoperative follow-up assessments. Additionally, they should possess the necessary civil capacity, be capable of reading and writing, and willingly provide informed consent by signing the consent form.\n3. Participants must be at least 22 years old at the time of their implantation surgery.\n\nExclusion Criteria:\n\n* Not applicable'}, 'identificationModule': {'nctId': 'NCT06510205', 'briefTitle': 'The Study is an Oberservational Post-market Follow-up Program to Evaluate Long Term(5 Years) Safety of Mentor Breast Implants in Chinese Population.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Medical (Shanghai) Ltd.'}, 'officialTitle': 'Post-Market Clinical Follow-up for Mentor Breast Implants', 'orgStudyIdInfo': {'id': 'MNT202401'}, 'secondaryIdInfos': [{'id': 'MNT202401', 'type': 'OTHER', 'domain': 'Johnson & Johnson Medical (Shanghai) Ltd'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mentor Group', 'description': 'Who recieves Mentor breast implants per request', 'interventionNames': ['Device: Mentor Breast implants']}], 'interventions': [{'name': 'Mentor Breast implants', 'type': 'DEVICE', 'description': "Mentor breast implants are circular or waterdrop-shaped devices with shells made of successive cross-linked layers of silicone elastomer. The shell is filled with Mentor's proprietary formulation of silicone gel.\n\nMentor breast implants are available in smooth and textured shells, both supplied in sterile form.", 'armGroupLabels': ['Mentor Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610000', 'city': 'Chengdu', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Sichuan Huamei Zixin Medical Aesthetic Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '518000', 'city': 'Shenzhen', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Shenzhen Yixing Medical Cosmetology Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '519000', 'city': 'Shenzhen', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Shenzhen Junke Medical Cosmetology Clinic', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'Study Contact', 'role': 'CONTACT', 'email': 'ygu51@its.jnj.com', 'phone': '+86 15692105615'}], 'overallOfficials': [{'name': 'Huimin Wu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shenzhen Junke Medical Cosmetology Clinic'}]}, 'ipdSharingStatementModule': {'url': 'http://yoda.yale.edu', 'ipdSharing': 'YES', 'description': 'Johnson \\& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu\n\n.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Medical (Shanghai) Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}