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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P230005 / PAS001 |
| Date Original Protocol Accepted |
09/26/2024
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| Date Current Protocol Accepted |
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| Study Name |
Post-Approval PMA Cohorts Study - PACS
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| Device Name |
Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breast Implants
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| Clinical Trial Number(s) |
NCT03579901
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
continued follow-up of premarket cohort
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| Study Population |
Adult (age 22 and over) women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery to correct or improve the results of a primary breast augmentation or reconstruction surgery. There is no control group.
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| Sample Size |
Total subject population 800 subjects (approx. 1,510 implants) in four pivotal cohorts:
· 450 subjects: Primary Augmentation cohort
· 100 subjects: Revision Augmentation cohort
· 200 subjects: Primary Reconstruction
· 50 subjects: Revision Reconstruction cohort
There will be two sub-study groups for this study:
· Magnetic Resonance Imaging (MRI) Sub-Study: This group will be a sub-set of the treated population that will be selected to obtain MRIs at years 1, 2, 3, 5, 7, and 10. These data will be used for the analysis of silent rupture. A total of 250 subjects (approx. 475 implants) will be included in the MRI sub-study.
· Radiofrequency Identification Device (RFID) Microtransponder SubStudy Population: This group will be a subset of the treated population who elect to receive an optional RFID microtransponder that is embedded in their Motiva Implants®. A total of approximately 150 subjects will be included in the microtransponder sub-study.
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| Key Study Endpoints |
Effectiveness Endpoints:
The primary effectiveness endpoint is the assessment of patient satisfaction on a 5-point Likert scale at 2 years post-implant for all implantation groups. The subject will be considered satisfied if the response to this survey is “satisfied” or “very satisfied.”
Secondary effectiveness assessments will include the following analyses
· Patient Satisfaction with Breast (BREAST-Q™) Questionnaire by cohort (approximately 300 subjects to participate at baseline).
· Physician Satisfaction (5-point Likert scale) at 2 years post-implant [aggregate analysis and by cohort].
· Quality of Life (Rosenberg Self-Esteem Scale, SF-36, Body Esteem Scale) for all cohorts.
· Breast Measurements (Net Chest Circumference and HemiCircumference) change from baseline (for Primary Augmentation cohort only).
Safety Endpoints:
The primary safety endpoint is the total adverse event rate (“any complication)” through two years of follow-up. Kaplan-Meier analysis of adverse events will be conducted by time period for each type of adverse event.
Secondary safety assessments will include the following analyses:
· Kaplan-Meier analysis of all complications, including reoperation and explantation
· Cox regression analyses for the following endpoints: Capsular contracture III/IV, Breast Pain, Infection, and Implant Rupture.
· Kaplan-Meier analysis of rupture (based on the MRI sub-study cohort)
· Kaplan-Meier analysis of connective tissue disease (CTD) and CTD signs/symptoms
· Kaplan-Meier analysis of Cancer (Breast Cancer, Breast ImplantAssociated Anaplastic Large Cell Lymphoma (BIA-ALCL), and others)
· Additional events will be included in listings by level of seriousness and device and procedure-relatedness.
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| Follow-up Visits and Length of Follow-up |
10 years
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