Status:
RECRUITING
Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
Lead Sponsor:
W.L.Gore & Associates
Collaborating Sponsors:
Avania
Conditions:
Breast Reconstruction Surgery
Eligibility:
FEMALE
22+ years
Phase:
NA
Brief Summary
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, wh...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2030
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06556654
Start Date
April 9 2025
End Date
July 1 2030
Last Update
October 23 2025
Active Locations (20)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
2
University of Arizona
Tucson, Arizona, United States, 85724
3
The Regents of the University of California
Irvine, California, United States, 92697-7600
4
Cedars-Sinai Plastic and Reconstruction Surgery
Los Angeles, California, United States, 90048