Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation
Public ClinicalTrials.gov record NCT05945329. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Randomized, Controlled, Multi-Center Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05945329
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 250 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 22 Years to 70 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 11, 2024
- Primary completion
- Jan 31, 2029
- Completion
- Jan 31, 2029
- Last update posted
- May 21, 2026
2024 – 2029
United States locations
- U.S. sites
- 34
- U.S. states
- 18
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Defyne MD | Scottsdale | Arizona | 82521 | Recruiting |
| The Practice Plastic Surgery | Beverly Hills | California | 90210 | Recruiting |
| California Aesthetic Center | Huntington Beach | California | 92647 | Recruiting |
| Donald S Mowlds, MD A Professional Corporation | Newport Beach | California | 92660 | Recruiting |
| Newport Plastic and Reconstructive Surgery Associates | Newport Beach | California | 92660 | Recruiting |
| Stewart Wang MD Inc. | Pasadena | California | 91101 | Recruiting |
| Charlie Chen MD., Corp | San Diego | California | 92107 | Recruiting |
| Tim Sayed MD | San Diego | California | 92121 | Withdrawn |
| Beauty by Buford | Lone Tree | Colorado | 80124 | Recruiting |
| Sanctuary Plastic Surgery | Boca Raton | Florida | 33431 | Withdrawn |
| Careaga Plastic Surgery | Miami | Florida | 33134 | Recruiting |
| Aesthetic Enhancements Plastic Surgery | Orlando | Florida | 32819 | Recruiting |
| Billington Plastic Surgery | St. Petersburg | Florida | 33710 | Recruiting |
| VIVIFY Plastic Surgery | Tampa | Florida | 33606 | Recruiting |
| The Graivier Center | Alpharetta | Georgia | 30005 | Recruiting |
| Monarch Plastic Surgery and Skin Renewal Center | Atlanta | Georgia | 30328 | Recruiting |
| Meridian Plastic Surgery Center | Indianapolis | Indiana | 46290 | Recruiting |
| Northshore Plastic Surgery | Mandeville | Louisiana | 70448 | Recruiting |
| The Washington University | St Louis | Missouri | 63110 | Recruiting |
| Reno Tahoe Plastic Surgery | Reno | Nevada | 89511 | Recruiting |
| VIP Plastic Surgery | West Long Branch | New Jersey | 07764 | Recruiting |
| Plastic Surgery Institute of New York | New York | New York | 10036 | Recruiting |
| H/K/B Surgery | Huntersville | North Carolina | 28078 | Recruiting |
| Essential Medical Research | Tulsa | Oklahoma | 74137 | Withdrawn |
| Pittsburgh Center for Plastic Surgery | Pittsburgh | Pennsylvania | 15213 | Recruiting |
| The Plastic Surgery Center of Nashville With HKB | Nashville | Tennessee | 37203 | Recruiting |
| Farah Naz Khan | Dallas | Texas | 75219 | Recruiting |
| Southwest Plastic Surgery | El Paso | Texas | 79936 | Recruiting |
| Aesthetic Center for Plastic Surgery | Houston | Texas | 77024 | Recruiting |
| Hill Country Plastic Surgery | San Antonio | Texas | 78257 | Recruiting |
| Next Stage Clinical Research | San Antonio | Texas | 78258 | Terminated |
| The Plastics Clinic | Draper | Utah | 84020 | Recruiting |
| Athenix Advanced Plastic Surgery & Aesthetic Center | Seattle | Washington | 98005 | Recruiting |
| Allen Gabriel MD | Vancouver | Washington | 98660 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05945329, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 21, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05945329 live on ClinicalTrials.gov.