A Prospective, Randomized, Controlled, Multi-Center Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation
C. R. Bard is conducting a multi-center, randomized controlled trial to evaluate the safety and effectiveness of the GalaFLEX LITE™ Scaffold in reducing capsular contracture recurrence in breast augmentation patients. The study aims to enroll between 250 and 530 subjects and compares the scaffold's performance against standard surgical procedures.
Indication: Capsular Contracture Associated With Breast Implant
Modality: medical device
Target: Capsular Contracture After Breast Implant Augmentation
Sponsor: C. R. Bard
Source URL: ClinicalTrials.gov
Source updated: May 22, 2026
Ingested: May 30, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: Capsular Contracture After Breast Implant Augmentation
View original source fields
Condition raw: Capsular Contracture Associated With Breast Implant
Condition normalized: Capsular Contracture Associated With Breast Implant
Modality raw: Capsular Contracture Associated With Breast Implant
Modality normalized: medical device
Target raw: Capsular Contracture After Breast Implant Augmentation
Target normalized: Capsular Contracture After Breast Implant Augmentation