Actively Recruiting
Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation
Led by C. R. Bard · Updated on 2026-03-10
250
Participants Needed
32
Research Sites
216 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Genetically female aged 22 to 66 years
- Have Baker grade III or IV capsular contracture after breast augmentation
- Desire a new implant with no more than a 25% increase in size and not exceeding 150cc volume increase
- Plan revision surgery using an inframammary fold incision
- Willing and able to follow study procedures including 2-year follow-up
- Live within 3 hours driving distance from the study site
- Provide signed and dated informed consent
You will not qualify if you...
- Body Mass Index (BMI) less than 18 or greater than 35
- Existing or replacement implant size greater than 800 cc
- Had two or more prior capsular contracture revisions on the treated breast(s)
- Have extracapsular implant rupture in the breast(s) to be treated
- Prior use of any synthetic or biologic matrix in the breast(s) to be treated
- Abnormal diagnostic imaging within 1 year of enrollment (mammogram, MRI, or ultrasound as appropriate)
- Symptoms consistent with Breast Implant Illness or Systemic Symptoms Associated with Breast Implants
- Breast infection at time of surgery
- Currently or recently (within 3 months) breastfeeding or history of mastitis within 6 months
- Prior or current breast cancer diagnosis
- Palpable breast mass not confirmed benign by imaging or biopsy
- Prior chest radiation treatment
- Chemotherapy within last 12 months
- Current or recent (within 1 year) alcohol or substance abuse
- Current or recent nicotine use within 4 weeks, including cigarettes, vaping, patches, gum
- History of Breast Implant-Associated Anaplastic Large Cell Lymphoma or Breast Implant Associated Squamous Cell Carcinoma
- Planned use of another matrix type in addition to GalaFLEX LITE22
- Use of medical, physical, or device-assisted tools to manage breast capsules
- Medical conditions posing high risk of complications (e.g., insulin-dependent diabetes, autoimmune diseases, connective tissue disorders, chronic lung or severe cardiovascular disease)
- Planned or concurrent elective cosmetic breast surgery during study follow-up
- Enrollment in another interfering clinical study
- Pregnant or planning pregnancy during study period
- Allergy to tetracycline hydrochloride or kanamycin sulfate
- Any condition preventing study device use or outcome evaluation
- Not remaining under investigator's care for all plastic surgery procedures during study
- Active use of immunosuppressants such as oral steroids or biological therapies
- Diagnosis of certain rheumatic or connective tissue diseases
- Mental illness or disability precluding study participation
- Breast implant was never commercially available in the USA
- Implanted with any silicone implant other than breast implants
- Taking drugs affecting blood clotting or increasing risk of complications
- Employment or close relation to study sponsor, surgeon, or study staff
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
Defyne MD
Scottsdale, Arizona, United States, 82521
Actively Recruiting
2
The Practice Plastic Surgery
Beverly Hills, California, United States, 90210
Actively Recruiting
3
California Aesthetic Center
Huntington Beach, California, United States, 92647
Actively Recruiting
4
Donald S Mowlds, MD A Professional Corporation
Newport Beach, California, United States, 92660
Actively Recruiting
5
Newport Plastic and Reconstructive Surgery Associates
Newport Beach, California, United States, 92660
Actively Recruiting
6
Stewart Wang MD Inc.
Pasadena, California, United States, 91101
Actively Recruiting
7
Charlie Chen MD., Corp
San Diego, California, United States, 92107
Actively Recruiting
8
Tim Sayed MD
San Diego, California, United States, 92121
Withdrawn
9
Beauty by Buford
Lone Tree, Colorado, United States, 80124
Actively Recruiting
10
Sanctuary Plastic Surgery
Boca Raton, Florida, United States, 33431
Withdrawn
11
Careaga Plastic Surgery
Miami, Florida, United States, 33134
Actively Recruiting
12
Aesthetic Enhancements Plastic Surgery
Orlando, Florida, United States, 32819
Actively Recruiting
13
Billington Plastic Surgery
St. Petersburg, Florida, United States, 33710
Actively Recruiting
14
VIVIFY Plastic Surgery
Tampa, Florida, United States, 33606
Actively Recruiting
15
The Graivier Center
Alpharetta, Georgia, United States, 30005
Actively Recruiting
16
Monarch Plastic Surgery and Skin Renewal Center
Atlanta, Georgia, United States, 30328
Actively Recruiting
17
Meridian Plastic Surgery Center
Indianapolis, Indiana, United States, 46290
Actively Recruiting
18
Reno Tahoe Plastic Surgery
Reno, Nevada, United States, 89511
Actively Recruiting
19
VIP Plastic Surgery
West Long Branch, New Jersey, United States, 07764
Actively Recruiting
20
Plastic Surgery Institute of New York
New York, New York, United States, 10036
Actively Recruiting
21
H/K/B Surgery
Huntersville, North Carolina, United States, 28078
Actively Recruiting
22
Essential Medical Research
Tulsa, Oklahoma, United States, 74137
Withdrawn
23
Pittsburgh Center for Plastic Surgery
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
24
The Plastic Surgery Center of Nashville With HKB
Nashville, Tennessee, United States, 37203
Actively Recruiting
25
Farah Naz Khan
Dallas, Texas, United States, 75219
Actively Recruiting
26
Southwest Plastic Surgery
El Paso, Texas, United States, 79936
Actively Recruiting
27
Aesthetic Center for Plastic Surgery
Houston, Texas, United States, 77024
Actively Recruiting
28
Hill Country Plastic Surgery
San Antonio, Texas, United States, 78257
Actively Recruiting
29
Next Stage Clinical Research
San Antonio, Texas, United States, 78258
Actively Recruiting
30
The Plastics Clinic
Draper, Utah, United States, 84020
Actively Recruiting
31
Athenix Advanced Plastic Surgery & Aesthetic Center
Seattle, Washington, United States, 98005
Actively Recruiting
32
Allen Gabriel MD
Vancouver, Washington, United States, 98660
Actively Recruiting
Research Team
N
Niccole Diaz
CONTACT
J
Jenna Baccari
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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