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General |
Study Status |
Study Pending |
Application Number / Requirement Number |
P230005 / PAS002 |
Date Original Protocol Accepted |
11/22/2024
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Date Current Protocol Accepted |
 
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Study Name |
New Enrollment Post-Approval Study
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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 |
Concurrent 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 |
Prospective, non-randomized, multicenter study including baseline (preoperative), operative, and postoperative data collection at baseline and annually Years 1-10 The Post Approval Study is a new enrollment study that will examine the general post market use and endpoints not addressed during premarket studies in women who are undergoing primary augmentation and revision augmentation breast surgery to correct or improve the results of a primary breast augmentation, and in a group of control subjects undergoing an aesthetic procedure other than breast implant surgery
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Study Population |
Subject population of 2,400 subjects in three cohorts: - 1,500 primary augmentation subjects implanted with approved Motiva devices - 500 revision augmentation subjects implanted with approved Motiva devices - 400 control subjects consisting of women undergoing an aesthetic procedure other than breast implant surgery
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Sample Size |
Number of subjects: 2400 Assumptions for sample size estimation: Sufficient sample size assuming worst-case (40%) loss-to-follow-up to have sufficient power (at least 80%) to detect a 2.0 odds ratio for CTD and systemic signs and symptoms differences between the Motiva group and Control group when the incidence in the control group is at least 10%. Number of sites: 50 Sites location: in the US
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Key Study Endpoints |
Safety Endpoints Primary: Patient-reported incidence of CTD and systemic signs and symptoms using a questionnaire including the PROMIS-29 Survey, a validated tool that assesses eight health domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference and cognitive functions and compare them among study groups (i.e., implanted vs control) Secondary: - Patient-reported incidence of reproductive complications, cancer (including breast cancer), local complications (including suspected rupture), reoperation, implant removal comparing (a) Round to Round Ergonomix devices, (b) Non-White participants to White participants, (c) RFID devices to non-RFID devices, and d) Implanted vs Controls, where data collection allows - Assess the impact of RFID on imaging (MRI or ultrasound) Effectiveness Endpoints Primary: none Secondary: Patient Satisfaction
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Follow-up Visits and Length of Follow-up |
Annual follow-up visit (questionnaire) administered annually for 10 years.
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