Jacksonville, FLNCT06556654Now EnrollingIRB Ready

Breast Reconstruction Surgery Clinical Trial in Jacksonville, FL

Access cutting-edge breast reconstruction surgery treatment through this clinical trial at a research site in Jacksonville. Study-provided care at no cost to qualified participants.

Sponsored by W.L.Gore & Associates

Quick Self-Assessment

See if you qualify for this Jacksonville location

Preparing your pre-screening questions…

Expert Care in Jacksonville

Access breast reconstruction surgery specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related breast reconstruction surgery treatment provided free

Apply for This Jacksonville Location

Check if you qualify for this breast reconstruction surgery clinical trial in Jacksonville, FL

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Jacksonville

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Jacksonville site if eligible
  4. 4Begin participation

About This Breast Reconstruction Surgery Study in Jacksonville

The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures. There will be two arms in this study, a Treatment Arm, where data will be collected for a new medical device called the Tissue Reinforcement for Breast Reconstruction (TRBR) Device and a Control Arm where data will be collected from subjects who have previously had surgery and received no additional tissue reinforcement in their breast reconstruction surgery. This research study will look at the safety of the Study Device and the success of the participants breast reconstruction. The Study Device is investigational, which means it has not yet been used nor approved by the FDA for this treatment. The data collected in this study will be compared to the data collected in the Control Arm.

Sponsor: W.L.Gore & Associates

Who Can Participate

Inclusion Criteria

Female subjects ≥ 22 years of age.
First-time breast reconstruction post-mastectomy for target breast(s).
Scheduled to undergo unilateral or bilateral mastectomy with immediate, two-stage, implant-based, subpectoral or prepectoral breast reconstruction after mastectomy.
Mastectomy performed to address breast cancer or for cancer prophylaxis.
An informed consent form is signed by Subject or Legally Authorized Representative (LAR).
Subject is capable of following protocol procedures and complying with follow-up visit requirements

Exclusion Criteria

Baseline Exclusion Criteria
Subject has had a revision(s) in the target breast(s) following complications of breast augmentation, mastopexy (breast lift), or breast reduction.
Subject has undergone previous radiation therapy to the reconstruction site or chest wall.
Subject has had chemotherapy within 3 weeks prior to the index procedure.
Subject has been treated for a systemic infection or local infection at the surgical site within 30 days prior to index procedure.
Subject has a current or previous diagnosis of Methicillin-resistant Staphylococcus aureus (MRSA).
Subject has a BMI \> 35.
Subject has a known diagnosis of diabetes with a HbA1c \> 7.0mmol/L within 30 days of the Index procedure (i.e., TE placement).
Subject was a current or former tobacco/nicotine user, within 90 days prior to Index Surgery (i.e., TE placement).
Subject is currently taking medication (e.g., systemic steroid), which in the investigator's opinion, may increase the risk of local complications of breast reconstruction.
Subject has other medical, social, or psychological conditions which could interfere with provision of informed consent, completion of tests, therapy, or follow-up.
Subject is currently participating in or planning to participate in another investigational drug, biologic or medical device study that may interfere with compliance of TBR 22-07 study requirements or may confound TBR 22-07 study data/outcomes.
Subject requires a surgical technique requiring flap (autologous tissue).
Subject is pregnant or lactating at the time of the index procedure (i.e., TE placement) or is planning to become pregnant prior to the Exchange procedure. Intraoperative Index Procedure Exclusion
Based on investigator's opinion, subject has unsuitable tissue integrity for immediate 2-stage breast reconstruction or is no longer a candidate to receive the TRBR Device (will be recorded as a screen failure).
Subject receives an Acellular Dermal Matrix (ADM) or mesh that is not the TRBR Device in the target breast(s)

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 Jacksonville?

Yes, this clinical trial (NCT06556654) has an active research site in Jacksonville, FL 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.

Breast Reconstruction Surgery Treatment Options in Jacksonville, FL

If you're searching for breast reconstruction surgery treatment options in Jacksonville, FL, this clinical trial (NCT06556654) 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 Jacksonville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced breast reconstruction surgery 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 breast reconstruction surgery clinical trials near you to find additional studies recruiting in your area.

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