Condition: Capsular Contracture Associated With Breast Implant · Capsular Contracture Grade III · Capsular Contracture Grade IV · Sponsor: C. R. Bard
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.
This description comes directly from the study's public registry record.
Niccole Diaz · 407-694-0553 · Niccole.Diaz@bd.com
Jenna Baccari · jenna.baccari@bd.com
Always discuss trial participation with your own doctor first.
| Defyne MD | Scottsdale, Arizona, United States | Recruiting |
| The Practice Plastic Surgery | Beverly Hills, California, United States | Recruiting |
| California Aesthetic Center | Huntington Beach, California, United States | Recruiting |
| Donald S Mowlds, MD A Professional Corporation | Newport Beach, California, United States | Recruiting |
| Newport Plastic and Reconstructive Surgery Associates | Newport Beach, California, United States | Recruiting |
| Stewart Wang MD Inc. | Pasadena, California, United States | Recruiting |
| Charlie Chen MD., Corp | San Diego, California, United States | Recruiting |
| Tim Sayed MD | San Diego, California, United States | Withdrawn |
| Beauty by Buford | Lone Tree, Colorado, United States | Recruiting |
| Sanctuary Plastic Surgery | Boca Raton, Florida, United States | Withdrawn |
| Careaga Plastic Surgery | Miami, Florida, United States | Recruiting |
| Aesthetic Enhancements Plastic Surgery | Orlando, Florida, United States | Recruiting |
+ 22 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05945329