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

NARecruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

December 12, 2024

Primary Completion Date

January 31, 2027

Study Completion Date

January 31, 2027

Conditions
Capsular Contracture Associated With Breast ImplantCapsular Contracture Grade IIICapsular Contracture Grade IV
Interventions
DEVICE

GalaFLEX LITE™ Scaffold

Bioabsorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB) and knitted into a surgical scaffold used to reinforce soft tissue

OTHER

Standard surgery

Surgery performed without the use of a scaffold

Trial Locations (15)

10036

RECRUITING

Plastic Surgery Institute of New York, New York

28078

RECRUITING

H/K/B Surgery, Huntersville

33431

RECRUITING

Sanctuary Plastic Surgery, Boca Raton

33710

RECRUITING

Billington Plastic Surgery, St. Petersburg

37203

RECRUITING

The Plastic Surgery Center of Nashville With HKB, Nashville

46290

RECRUITING

Meridian Plastic Surgery Center, Indianapolis

74137

RECRUITING

Essential Medical Research, Tulsa

77024

RECRUITING

Aesthetic Center for Plastic Surgery, Houston

79936

RECRUITING

Southwest Plastic Surgery, El Paso

84020

RECRUITING

The Plastics Clinic, Draper

90210

RECRUITING

The Practice Plastic Surgery, Beverly Hills

92121

RECRUITING

Tim Sayed MD, San Diego

92660

RECRUITING

Donald S Mowlds, MD A Professional Corporation, Newport Beach

RECRUITING

Newport Plastic and Reconstructive Surgery Associates, Newport Beach

98660

RECRUITING

Allen Gabriel MD, Vancouver

Sponsors

Lead Sponsor

All Listed Sponsors
lead

C. R. Bard

INDUSTRY