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

Study acronym: STANCE
StatusRecruiting
PhaseNot applicable
SponsorC. R. Bard
Started
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Record History

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  1. Site contacts updated at 6 of 37 sites
  2. Trial sites expanded: 34 → 37 locations
    • Eligibility criteria expanded, about 43 words
    • Secondary endpoints: details revised at 1 of 3 entries
  3. Study sites: 32 to 34
    • Eligibility criteria expanded, about 155 words
    v14
  4. Study sites: 30 to 32v13
  5. Primary and study completion dates: Jan 2027 to Feb 2029
    • Study sites: 20 to 30
    v12
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  1. Site details revised at 2 of 20 sitesv11
  2. Study sites: 15 to 20v10
  3. Study sites: 13 to 15v9
  4. Study sites: 9 to 13v8
  5. Study sites: 8 to 9v7
  6. Study sites: 6 to 8v6
  7. Lead sponsor: [Redacted] to C. R. Bardv5 Show 4 more changesShow less
    • Trial status: Withheld to Recruiting
    • Primary and study completion dates: Jan 2027
    • Start date: Dec 12, 2024
    • Study title expanded, about 1 word
  8. 3 versions Re-verified since Apr 11, 2024, no change to tracked fieldsv2-v4
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
C. R. Bard
11 trials monitored
See 2 trials at risk
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.
Trial Details
NCT Number NCT05945329
Lead Sponsor C. R. Bard
Conditions
(from sponsor)		 Capsular Contracture Associated With Breast Implant, Capsular Contracture Grade III, Capsular Contracture Grade IV
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov