Clinical Trial

Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation

Study acronym: STANCE
Recruiting
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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.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2023-07-06; most recent amendment 2026-05-21.
Status change: Withheld → Recruiting 2025-03-17
Trial Details
NCT Number NCT05945329
Lead Sponsor C. R. Bard
Conditions Capsular Contracture Associated With Breast Implant, Capsular Contracture Grade III, Capsular Contracture Grade IV
Enrollment 250 participants
Start Date 2024-12-12
Primary Completion 2029-02 (estimated)
Study Completion 2029-02 (estimated)
Updated on ClinicalTrials.gov 2026-05-22