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NCT05945329 · ClinicalTrials.gov registry record · NA
Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation
A NA study of Capsular Contracture Associated With Breast Implant and Capsular Contracture Grade III, sponsored by C. R. Bard.
- Recruiting
- Registry status
- NA
- Development phase
- 250
- Enrollment target
- 20
- Study locations
NCT05945329: Recruiting NA study of Capsular Contracture Associated With Breast Implant and Capsular Contracture Grade III, sponsored by C. R. Bard.
NCT05945329 is a NA study of Capsular Contracture Associated With Breast Implant and Capsular Contracture Grade III that is actively recruiting participants, run by C. R. Bard. The registered enrollment target is 250 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05945329, a NA study of Capsular Contracture Associated With Breast Implant and Capsular Contracture Grade III, is actively recruiting participants, sponsored by C. R. Bard.
- RECRUITING
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
- 20
- Study locations
Study Summary
Prospective, randomized, controlled study to assess the safety and effectiveness of GalaFLEX LITE™ Scaffold in revision surgery for reduction of capsular contracture recurrence and/or malposition in implant-based breast augmentation patients versus patients undergoing conventional revision surgery with no supportive matrix or acellular dermal matrix (ADM). Subjects will be randomized 2:1 to receive either GalaFLEX LITE™ Scaffold or standard care (no ADM or matrix placement). This study is designed using an adaptive approach. The number of the treated breasts will range between 250 and 530.
Primary Outcome
Composite of Recurrent Capsular Contracture Baker grade III/IV and/or breast implant malposition
Conditions Studied
Interventions
- DEVICE GalaFLEX LITE™ Scaffold
- OTHER Standard surgery
Study Locations (20)
California
- The Practice Plastic Surgery - Beverly Hills
- California Aesthetic Center - Huntington Beach
- Donald S Mowlds, MD A Professional Corporation - Newport Beach
- Newport Plastic and Reconstructive Surgery Associates - Newport Beach
- Stewart Wang MD Inc. - Pasadena
- Charlie Chen MD., Corp - San Diego
- Tim Sayed MD - San Diego
Florida
- Sanctuary Plastic Surgery - Boca Raton
- Careaga Plastic Surgery - Miami
- Aesthetic Enhancements Plastic Surgery - Orlando
- Billington Plastic Surgery - St. Petersburg
- VIVIFY Plastic Surgery - Tampa
Georgia
- The Graivier Center - Alpharetta
- Monarch Plastic Surgery and Skin Renewal Center - Atlanta
Arizona
- Defyne MD - Scottsdale
Colorado
- Beauty by Buford - Lone Tree
Indiana
- Meridian Plastic Surgery Center - Indianapolis
Nevada
- Reno Tahoe Plastic Surgery - Reno
New Jersey
- VIP Plastic Surgery - West Long Branch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2024-12-12 |
| Est. Completion | 2029-02 |
| Phase | NA |
What NCT05945329 shows while recruiting
NCT05945329 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Capsular Contracture Associated With Breast Implant appearing as the primary indexed condition, and to 2 interventions - of which GalaFLEX LITE™ Scaffold is the first listed.
NCT05945329 names 20 study sites across 9 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT05945329 about?
NCT05945329 is a clinical study titled "Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation". Prospective, randomized, controlled study to assess the safety and effectiveness of GalaFLEX LITE™ Scaffold in revision surgery for reduction of capsular contracture recurrence and/or malposition in implant-based breast augmentation patients versus patients undergoing conventional revision surgery w...
What is the current status of trial NCT05945329?
This trial is currently recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2024-12-12. Estimated completion is 2029-02.
What conditions does trial NCT05945329 study?
This clinical trial studies the following conditions: Capsular Contracture Associated With Breast Implant, Capsular Contracture Grade III, Capsular Contracture Grade IV.
What interventions are being tested in trial NCT05945329?
The interventions under investigation include: GalaFLEX LITE™ Scaffold (DEVICE), Standard surgery (OTHER).
Who is sponsoring clinical trial NCT05945329?
This trial is sponsored by C. R. Bard, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05945329 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05945329's enrollment target sits among peer trials
250 410th of 2000 higher than 1,567 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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