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

Recruiting now · Not applicable

Conditions studied: Capsular Contracture Associated With Breast Implant, Capsular Contracture Grade III, Capsular Contracture Grade IV

In brief

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.

Key facts

Study ID

NCT05945329

Run by

C. R. Bard

People needed

250

Starts

2024-12-12

Expected to finish

2029-02-01

Last updated by the study team

2026-05-22

Who can join

Age: 22 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Genetically female ≥22 and ≤70 years of age;
• Breast augmentation subject with capsular contracture (Baker grade III or IV);
• Desires a new silicone implant with no more than a ± 150cc volume change in implant size;
• Planned revision approach via inframammary fold (IMF) incision;
• Willing and able to comply with the study procedures including the 2-year follow-up visit;
• Can complete all required study visits as scheduled (i.e., physically attend);
• Has reviewed and completed an FDA required Breast Implant Patient Decision Checklist (e.g., implant-specific provided by the manufacturer);
• Has compatible smart technology that can be used for downloading/using the electronic patient diary; and,
• Provision of signed and dated informed consent form.

You may not qualify if…

• BMI <18 or >35
• Existing and/or replacement implant size > 800 cc
• Has an extra-capsular silicone breast implant rupture where silicone gel has leaked outside of the capsule) in breast(s) intended for treatment
• Has prior use of a matrix (synthetic or biologic) in the breast(s) intended for treatment
• Abnormal breast findings on imaging within 1-year prior to randomization that have not been determined to be benign
• Subject reported current, or prior history of, Systemic Symptoms Associated with Breast Implants (SSBI - formerly referred to as BII (Breast Implant Illness))
• Infection present in the study breast(s) (day of index procedure (surgery) exclusions)
• Current or recent breastfeeding (within 3-months of enrollment) or history of mastitis within the 6-months prior to enrollment
• Prior or current diagnosis of breast cancer
• Has a mass that was palpated and has not been determined benign via acceptable imaging (MRI) or biopsy results
• Has undergone prior chest radiation treatment
• Has received chemotherapy within the last 12 months
• Current or recent (within 1-year of enrollment) alcohol/substance abuse
• Current or recent (within 4-weeks of enrollment) nicotine user (includes cigarettes, vaping, patches, gum, etc.)
• History of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIAALCL) or Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC)
• Planned use of any other matrix (synthetic, biosynthetic, or biological) in the study breast(s) other than the GalaFLEX LITE™ Scaffold used to fully wrap the implant
• Planned (within the 2-year follow-up time period) use of medical (e.g. montelukast/Singulair; zafirlukast/Accolate), physical (e.g. massage), or device assisted (e.g. mechanical/thermal ultrasound) tools to manage the breast capsule(s)
• Any medical condition that, in the opinion of the investigator, may be associated with unduly high risk of intra- or post-operative complications (e.g., insulin dependent diabetes, autoimmune disease, connective tissue disorder, chronic lung or severe cardiovascular disease)
• Concurrent or planned use (within the 2-year follow-up time period) of autologous fat transfer in the study breast(s)
• Planned (within the 2-year follow-up time period) elective cosmetic surgery on the study breast(s) (e.g., staged mastopexy; revision for implant size change)
• Currently enrolled or has plans to enroll in another interventional clinical study that would interfere with this study
• Is pregnant or plans to become pregnant during the study period
• Known allergy to tetracycline hydrochloride and/or kanamycin sulfate
• Any condition that, in the Investigator's opinion, would preclude the use of the study device, interfere with the evaluation of the device or breast related outcomes
• Subject will not remain under the care of the investigator for all breast related plastic surgery procedures while enrolled in the study

Where it is running

• Allen Gabriel MD — Vancouver, Washington, United States (enrolling)
• The Practice Plastic Surgery — Beverly Hills, California, United States (enrolling)
• California Aesthetic Center — Huntington Beach, California, United States (enrolling)
• Donald S Mowlds, MD A Professional Corporation — Newport Beach, California, United States (enrolling)
• Newport Plastic and Reconstructive Surgery Associates — Newport Beach, California, United States (enrolling)
• Stewart Wang MD Inc. — Pasadena, California, United States (enrolling)
• Charlie Chen MD., Corp — San Diego, California, United States (enrolling)
• Hill Country Plastic Surgery — San Antonio, Texas, United States (enrolling)
• The Plastics Clinic — Draper, Utah, United States (enrolling)
• Athenix Advanced Plastic Surgery & Aesthetic Center — Seattle, Washington, United States (enrolling)
• Defyne MD — Scottsdale, Arizona, United States (enrolling)
• Beauty by Buford — Lone Tree, Colorado, United States (enrolling)
• Careaga Plastic Surgery — Miami, Florida, United States (enrolling)
• Aesthetic Enhancements Plastic Surgery — Orlando, Florida, United States (enrolling)
• Billington Plastic Surgery — St. Petersburg, Florida, United States (enrolling)
• VIVIFY Plastic Surgery — Tampa, Florida, United States (enrolling)
• The Graivier Center — Alpharetta, Georgia, United States (enrolling)
• Monarch Plastic Surgery and Skin Renewal Center — Atlanta, Georgia, United States (enrolling)
• Meridian Plastic Surgery Center — Indianapolis, Indiana, United States (enrolling)
• Northshore Plastic Surgery — Mandeville, Louisiana, United States (enrolling)
• The Washington University — St Louis, Missouri, United States (enrolling)
• Reno Tahoe Plastic Surgery — Reno, Nevada, United States (enrolling)
• VIP Plastic Surgery — West Long Branch, New Jersey, United States (enrolling)
• Plastic Surgery Institute of New York — New York, New York, United States (enrolling)
• H/K/B Surgery — Huntersville, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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