BridgeMD
New treatment option for Capsular Contracture Associated With Breast Implant
Official title Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation
ClinicalTrials.gov ID: NCT05945329
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 70, women only
You may be able to join 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;
You likely can't join if
- BMI \ 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...
See the full eligibility criteria
Who can 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);
- 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.
What rules you out
- BMI \ 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...
- 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...
- 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 treatment 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...
- 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...
- 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
- people planning to undergo significant weight loss utilizing surgical intervention or prescribed medication(s) (e.g., gastric bypass; gastric sleeve; GLP1 agonists). people with stable weight after previous surgery or...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Beverly Hills, California, United States
- Huntington Beach, California, United States
- Newport Beach, California, United States
- Pasadena, California, United States
- San Diego, California, United States
- Lone Tree, Colorado, United States
- Boca Raton, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- St. Petersburg, Florida, United States
- Tampa, Florida, United States
- Alpharetta, Georgia, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Mandeville, Louisiana, United States
- St Louis, Missouri, United States
- Reno, Nevada, United States
- West Long Branch, New Jersey, United States
- New York, New York, United States
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 22 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Beverly Hills, California, United States; Huntington Beach, California, United States; Newport Beach, California, United States; Pasadena, California, United States; San Diego, California, United States and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.