Status: Recruiting
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 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.
Participants needed: 250
Trial details
Age: 22-70Biological sex: FemaleType: InterventionalSponsor: C. R. BardUpdated: May 22, 2026Locations: 34
Eligibility criteria
Genetically female ≥22 and ≤70 years of age; [+8]
BMI <18 or >35 [+35]