Is NCT05945329 recruiting in Pasadena, CA?

Yes, NCT05945329 is currently recruiting participants at its Pasadena, CA location. This capsular contracture associated with breast implant clinical trial is actively enrolling qualified participants.

Is participation in this Pasadena clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Capsular Contracture Associated With Breast Implant Clinical Trial in Pasadena, CA

Q: How do I join the capsular contracture associated with breast implant clinical trial in Pasadena?

To join this clinical trial in Pasadena, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Capsular Contracture Associated With Breast Implant Study in Pasadena

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.

Sponsor: C. R. Bard

Who Can Participate

Inclusion Criteria

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.

Exclusion Criteria

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

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Pasadena?

Yes, this clinical trial (NCT05945329) has an active research site in Pasadena, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Capsular Contracture Associated With Breast Implant Treatment Options in Pasadena, CA

If you're searching for capsular contracture associated with breast implant treatment options in Pasadena, CA, this clinical trial (NCT05945329) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Pasadena research site is actively enrolling participants for this clinical trial. You'll receive care from experienced capsular contracture associated with breast implant specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all capsular contracture associated with breast implant clinical trials near you to find additional studies recruiting in your area.

Capsular Contracture Associated With Breast Implant Clinical Trial in Pasadena, CA

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