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Capsular Contracture Associated With Breast ImplantSTANCENCT05945329

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

A study testing GalaFLEX LITE™ Scaffold and Standard surgery in people with Capsular Contracture Associated With Breast Implant and Capsular Contracture Grade III, run by C. R. Bard at 37 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 22 to 70 years, women only
What is being tested?
GalaFLEX LITE™ Scaffold and Standard surgery
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
37 sitesUnited States
Study dates
12 Dec 2024to Feb 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
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  • 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.

Who cannot join

  • 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))
Show all 37Show fewer
  • 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
  • Actively using immunosuppressants such as oral steroids or biological therapies (inhalers or topical steroids are permitted)
  • Confirmed diagnosis of the following rheumatic diseases or syndromes: systemic lupus erythematosus, Sjorgren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
  • Has, in the investigator's opinion, a mental illness or disability that would preclude their participation in the study
  • Subject has an implant that was never commercially available in the United States
  • Has been implanted with any silicone implant other than breast implants
  • Is taking any drugs that would interfere with blood clotting or might result in elevated risk of significant postoperative complications (e.g., anticoagulants or antiplatelet medications such as Xarelto, Aspirin, or Eliquis. NSAIDs such as Celebrex, Ibuprofen, Meloxicam are not exclusionary).
  • Works for Sponsor or any of their subsidiaries, the study surgeon, or is helping to conduct the study or are directly related to anyone that works for BD or any of their subsidiaries or the study surgeons
  • Subjects planning to undergo significant weight loss utilizing surgical intervention or prescribed medication(s) (e.g., gastric bypass; gastric sleeve; GLP1 agonists). Subjects with stable weight after previous surgery or current GLP-1 agonists use are not excluded.
  • Day of Index Procedure (Surgery) Exclusion Criteria
  • Has an extra-capsular rupture (breast implant silicone gel has leaked outside of the capsule) in breast(s) intended for treatment
  • Suspicions of cancer from intraoperative capsule appearance such as capsule masses (based on surgical opinion/visual findings; does not require definitive pathology) inclusive of both BIA-ALCL and BIA-SCC; or,
  • Presence of a systemic infection, infection at the surgical site, or infection anywhere in the body at the time of surgery.

Trial locations and contacts

37 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Niccole Diaz contact

407-694-0553

Niccole.Diaz@bd.com

Jenna Baccari contact

jenna.baccari@bd.com

37 sites in 1 country

United States37 sites, 33 recruiting

  • The Graivier Center

    Alpharetta, Georgia, 30005

    Avery Miller, 770-772-0695, a.miller@thegraiviercenter.com

    David Hill, MD

    Recruiting

  • Monarch Plastic Surgery and Skin Renewal Center

    Atlanta, Georgia, 30328

    Ashlee Kenny, 404-250-3333, ashlee@monarchga.com

    Carmen Kavali

    Recruiting

  • The Practice Plastic Surgery

    Beverly Hills, California, 90210

    Star Skillens, 310 278-8200, star@thepracticeps.com

    Kelly Killeen, MD, FACS

    Recruiting

  • Sanctuary Plastic Surgery

    Boca Raton, Florida, 33431

    Withdrawn

  • Iteld Plastic Surgery

    Chicago, Illinois, 60642

    Kimmy Vu, 3127574505, kimmy@driteld.com

    Lawrence Iteld, MD

    Recruiting

  • Farah Naz Khan

    Dallas, Texas, 75219

    Matt Phillips, 469-437-5426, matt@khanplasticsurgery.com

    Farah Khan

    Recruiting

  • The Plastics Clinic

    Draper, Utah, 84020

    Xoey Gunn, (385) 337-3228, xgunn@theplasticsclinic.com

    Jerry Chidester

    Recruiting

  • Southwest Plastic Surgery

    El Paso, Texas, 79936

    Michael Sanchez, michael@swplasticsurgery.com

    Frank Agullo

    Recruiting

  • Aesthetic Center for Plastic Surgery

    Houston, Texas, 77024

    Kirk Zihlman, kzihlman@kalonaesthetics.com

    Kristi Hustak

    Recruiting

  • H/K/B Surgery

    Huntersville, North Carolina, 28078

    Devin White, 704-659-2529 ext. 145, Devin@hkbsurgery.com

    Bill Kortesis, MD, FACS

    Recruiting

  • California Aesthetic Center

    Huntington Beach, California, 92647

    Tracy Bui-Vu, (714) 848-1133, tracy@stevevumd.com

    Steve Vu

    Recruiting

  • Meridian Plastic Surgery Center

    Indianapolis, Indiana, 46290

    Lisa Young, 317-575-0330, lyoung@meridianplastic.com

    Bruce W Van Natta

    Recruiting

  • Beauty by Buford

    Lone Tree, Colorado, 80124

    Kaylie Delacerda, 609-964-7993, kaylie@kerloresearch.com

    Gregory Buford

    Recruiting

  • Northshore Plastic Surgery

    Mandeville, Louisiana, 70448

    Erin Peak, 985-237-6050, erin@drboudreaux.com

    Jeffrey Claiborne

    Recruiting

  • Careaga Plastic Surgery

    Miami, Florida, 33134

    Barbara Garcia, 305-574-9262, bgarcia@absolutemedicalcenter.com

    Daniel Careaga, MD

    Recruiting

  • The Plastic Surgery Center of Nashville With HKB

    Nashville, Tennessee, 37203

    LaTasha Bolden, 615-467-6777, latasha@nashvillesurgery.com

    Kayla Sturdivant, kayla@nashvillesurgery.com

    Recruiting

  • Luxurgery

    New York, New York, 10021

    Christina Uong, 212-508-0000, cku@luxurgery.com

    Sachin Shridharani, MD

    Recruiting

  • Plastic Surgery Institute of New York

    New York, New York, 10036

    Matthew DelMauro, 646-257-2677, DrDelMauro@BodySculptingCenterNYC.com

    Matthew DelMauro, MD

    Recruiting

  • Donald S Mowlds, MD A Professional Corporation

    Newport Beach, California, 92660

    Mallory Painter, 949-759-5539, mallory@donaldmowldsmd.com

    Donald S Mowlds, MD

    Recruiting

  • Newport Plastic and Reconstructive Surgery Associates

    Newport Beach, California, 92660

    Christine Puentes, 949-251-1502, christinep@newportplastic.com

    Hisham Seify

    Recruiting

  • Aesthetic Enhancements Plastic Surgery

    Orlando, Florida, 32819

    Ashley Czarniak, 407-218-4550, ashley@drarmandosoto.com

    Armando Soto

    Recruiting

  • Scazorla Plastic Surgery

    Orlando, Florida, 32827

    Christian Trinidad, 407-313-1040, c.trinidad@nabellaplasticsurgery.com

    Sarah Cazorla, MD

    Recruiting

  • Stewart Wang MD Inc.

    Pasadena, California, 91101

    Dulce Valenzuela, 626-796-6680, dulce@wangplasticsurgery.com

    Stewart Wang

    Recruiting

  • Pittsburgh Center for Plastic Surgery

    Pittsburgh, Pennsylvania, 15213

    LeeAnn Fowler, 412-802-6100, lfowler@pghplasticsurgery.com

    Armando Davila, MD

    Recruiting

  • Reno Tahoe Plastic Surgery

    Reno, Nevada, 89511

    Erika Jolley, 775-284-2020, erika@drmccormack.com

    Tiffany McCormack, MD

    Recruiting

  • Hill Country Plastic Surgery

    San Antonio, Texas, 78257

    Sylvia Trujillo, 210-658-3555, Sylvia.Trujillo@hillcountryps.com

    Amita Shah

    Recruiting

  • Next Stage Clinical Research

    San Antonio, Texas, 78258

    Terminated

  • Charlie Chen MD., Corp

    San Diego, California, 92107

    Aimee Beltran, 858-255-1538, info@charliechenmd.com

    Charlie Chen

    Recruiting

  • Tim Sayed MD

    San Diego, California, 92121

    Withdrawn

  • Defyne MD

    Scottsdale, Arizona, 82521

    Amy Norzagaray, 480-561-6185, manager@defynemd.com

    Oren Tessler

    Recruiting

  • Athenix Advanced Plastic Surgery & Aesthetic Center

    Seattle, Washington, 98005

    Kathy Ross, 425-307-3546, drdry@athenixbody.com

    Gavin Dry

    Recruiting

  • The Washington University

    St Louis, Missouri, 63110

    Jeremy Eisele, 314-362-4639, jeisele@wustl.edu

    Justin Sacks

    Recruiting

  • Billington Plastic Surgery

    St. Petersburg, Florida, 33710

    Nicole Costa, 727 341-0337, nicole@billingtonmd.com

    Alicia Billington, MD

    Recruiting

  • VIVIFY Plastic Surgery

    Tampa, Florida, 33606

    Marlie Marino, 386-986-7010, Marlie@vivifyps.com

    Dallas Buchanan, MD

    Recruiting

  • Essential Medical Research

    Tulsa, Oklahoma, 74137

    Withdrawn

  • Allen Gabriel MD

    Vancouver, Washington, 98660

    Olivia Develasco, Olivia@allengabrielmd.com

    Allen Gabriel

    Recruiting

  • VIP Plastic Surgery

    West Long Branch, New Jersey, 07764

    Paige Dalton, 7329630809, paige@doctorvnj.com

    Rahul Vemula

    Recruiting

Other trials in United States

About this study

Official title: A Prospective, Randomized, Controlled, Multi-Center Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation

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.

Read the detailed description

Capsular contracture is the number one complication leading to revision surgery after breast augmentation(2-4) which has been commonly cited as impacting 10 to 20% of all breast augmentation patients.(5-10) A prospective, randomized controlled study of patients presenting with Baker grade III or IV capsular contracture will be undertaken to investigate the ability of P4HB (specifically GalaFLEX LITE™ Scaffold) to reduce the recurrence of clinically significant CC and/or malposition requiring surgical correction. The primary endpoint is a composite of capsular contracture recurrence and/or breast implant malposition recommended for surgery OR breast infections requiring oral or IV antibiotic treatment within 90 days of surgery and/or peri-implant fluid collection needing a drainage procedure within 10-90 days of surgery.

Being tested
GalaFLEX LITE™ Scaffold, Standard surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GalaFLEX LITE™ ScaffoldDevice

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

  • Standard surgeryOther

    Surgery performed without the use of a scaffold

Study groups in NCT05945329
Study groupRoleWhat they receive
GalaFlex Light ScaffoldExperimentalSurgery performed with GalaFlex Lite Scaffold.
Receives: Device: GalaFLEX LITE™ Scaffold
Standard SurgeryActive comparatorSurgery performed using standard surgical procedures with no scaffold.
Receives: Other: Standard surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24-months after index surgery

Secondary outcomes (3)

  1. Patient quality of life and satisfaction (12-month)

    Select Breast-Q© modules (standardized patient survey) for the treated breast(s): psychosocial wellbeing; sexual wellbeing; satisfaction with breasts; and physical wellbeing - chest

    Measured: 12-months after index surgery

  2. Patient quality of life and satisfaction

    Select Breast-Q© modules (standardized patient survey) for the treated breast(s): psychosocial wellbeing; sexual wellbeing; satisfaction with breasts; and physical wellbeing - chest

    Measured: 24-months after index surgery

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

    The occurrence of:

    • Breast fluid collection requiring a drainage procedure at any time, or after drain removal if one is used, within 90 days of surgery
    • Breast infection requiring oral (PO) or intravenous (IV) antibiotics related to the contracture revision surgery within 90 days of surgery

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2023
  2. Study start12 Dec 2024
  3. Primary completionFeb 2029 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multi-center, prospective, randomized
Masking
Single blind
Who is masked
Participant
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05945329
Sponsor's protocol ID
DVL-BR-001
Acronym
STANCE
Status last verified
Sep 2026
First submitted
6 Jul 2023
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing GalaFLEX LITE™ Scaffold and Standard surgery in people with Capsular Contracture Associated With Breast Implant and Capsular Contracture Grade III, run by C. R. Bard at 37 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Niccole Diaz (407-694-0553, Niccole.Diaz@bd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of GalaFLEX LITE™ Scaffold for the stabilization of the implant pocket (time frame: 24-months after index surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05945329.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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