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

NCT05945329 | Recruiting DMC FDA Device

• 1 other identifier: DVL-BR-001
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 32

Brief Summary

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

Capsular Contracture Grade III; Capsular Contracture Grade IV; Capsular Contracture Associated With Breast Implant

Outcome Measures

Primary Outcomes (1)

• Effectiveness of GalaFLEX LITE™ Scaffold for the stabilization of the implant pocket

  Composite of Recurrent Capsular Contracture Baker grade III/IV and/or breast implant malposition

  24-months after index surgery

Secondary Outcomes (3)

• Patient quality of life and satisfaction (12-month)

  12-months after index surgery

• Patient quality of life and satisfaction

  24-months after index surgery

• Safety of GalaFLEX LITE™ Scaffold for the stabilization of the implant pocket, reduction of capsular contracture recurrence, and/or malposition

  90 days

Other Outcomes (1)

• Device or procedure related adverse events

  24-months after index surgery

Study Arms (2)

GalaFlex Light Scaffold

EXPERIMENTAL

Surgery performed with GalaFlex Lite Scaffold.

Device: GalaFLEX LITE™ Scaffold

Standard Surgery

ACTIVE COMPARATOR

Surgery performed using standard surgical procedures with no scaffold.

Other: Standard surgery

Interventions

GalaFLEX LITE™ Scaffold DEVICE

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

GalaFlex Light Scaffold

Standard surgery OTHER

Surgery performed without the use of a scaffold

Standard Surgery

Eligibility Criteria

• Age: 22 Years - 66 Years
• Gender Eligibility Details: Genetically female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Genetically female ≥22 and ≤66 years of age;
• Breast augmentation subject with capsular contracture (Baker grade III or IV);
• Desired a new implant with no more than a 25% increase in implant size (not to exceed a volume increase greater than 150cc compared to the existing implant);
• Planned revision approach via inframammary fold (IMF) incision;
• Willing and able to comply with the study procedures including the 2-year follow-up visit;
• Lives within 3 hours driving distance from the investigator site; 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
• Had ≥2 capsular contracture revisions on the breast(s) intended for treatment
• Has an extra-capsular rupture (breast implant silicone gel or saline 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 findings on diagnostic imaging within 1-year of study enrollment (mammogram for patients ≥35 years old; MRI for patients \<35 years old or breast ultrasound if MRI is contraindicated)
• Has symptoms consistent with Breast Implant Illness (BII)Systemic Symptoms Associated with Breast Implants (SSBI)
• Current or recent breast feeding (within 3-months or 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 (BIA-ALCL) or Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC)

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (32)

Defyne MD

Scottsdale, Arizona, 82521, United States

RECRUITING

The Practice Plastic Surgery

Beverly Hills, California, 90210, United States

RECRUITING

California Aesthetic Center

Huntington Beach, California, 92647, United States

RECRUITING

Donald S Mowlds, MD A Professional Corporation

Newport Beach, California, 92660, United States

RECRUITING

Newport Plastic and Reconstructive Surgery Associates

Newport Beach, California, 92660, United States

RECRUITING

Stewart Wang MD Inc.

Pasadena, California, 91101, United States

RECRUITING

Charlie Chen MD., Corp

San Diego, California, 92107, United States

RECRUITING

Tim Sayed MD

San Diego, California, 92121, United States

WITHDRAWN

Beauty by Buford

Lone Tree, Colorado, 80124, United States

RECRUITING

Sanctuary Plastic Surgery

Boca Raton, Florida, 33431, United States

WITHDRAWN

Careaga Plastic Surgery

Miami, Florida, 33134, United States

RECRUITING

Aesthetic Enhancements Plastic Surgery

Orlando, Florida, 32819, United States

RECRUITING

Billington Plastic Surgery

St. Petersburg, Florida, 33710, United States

RECRUITING

VIVIFY Plastic Surgery

Tampa, Florida, 33606, United States

RECRUITING

The Graivier Center

Alpharetta, Georgia, 30005, United States

RECRUITING

Monarch Plastic Surgery and Skin Renewal Center

Atlanta, Georgia, 30328, United States

RECRUITING

Meridian Plastic Surgery Center

Indianapolis, Indiana, 46290, United States

RECRUITING

Reno Tahoe Plastic Surgery

Reno, Nevada, 89511, United States

RECRUITING

VIP Plastic Surgery

West Long Branch, New Jersey, 07764, United States

RECRUITING

Plastic Surgery Institute of New York

New York, New York, 10036, United States

RECRUITING

H/K/B Surgery

Huntersville, North Carolina, 28078, United States

RECRUITING

Essential Medical Research

Tulsa, Oklahoma, 74137, United States

WITHDRAWN

Pittsburgh Center for Plastic Surgery

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

The Plastic Surgery Center of Nashville With HKB

Nashville, Tennessee, 37203, United States

RECRUITING

Farah Naz Khan

Dallas, Texas, 75219, United States

RECRUITING

Southwest Plastic Surgery

El Paso, Texas, 79936, United States

RECRUITING

Aesthetic Center for Plastic Surgery

Houston, Texas, 77024, United States

RECRUITING

Hill Country Plastic Surgery

San Antonio, Texas, 78257, United States

RECRUITING

Next Stage Clinical Research

San Antonio, Texas, 78258, United States

RECRUITING

The Plastics Clinic

Draper, Utah, 84020, United States

RECRUITING

Athenix Advanced Plastic Surgery & Aesthetic Center

Seattle, Washington, 98005, United States

RECRUITING

Allen Gabriel MD

Vancouver, Washington, 98660, United States

RECRUITING

Central Study Contacts

Niccole Diaz

CONTACT

407-694-0553; Niccole.Diaz@bd.com

Jenna Baccari

CONTACT

jenna.baccari@bd.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will not be made aware of whether they receive standard-of-care surgery or surgery with the study device. They will be made aware at the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, prospective, randomized

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 14, 2023
• Study Start: December 12, 2024
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (32)