Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
NCT ID: NCT06556654
Last Updated: 2025-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2025-04-09
2030-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Prospective Arm
Prospectively treated subjects who undergo two-stage implant-based breast reconstruction with the TRBR Device (TRBR Device group)
TRBR Device
The GORE® Tissue Reinforcement for Breast Reconstruction device is intended to reinforce the soft tissue surrounding the tissue expander in preparation for the breast implant in post-mastectomy breast reconstruction
Interventions
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TRBR Device
The GORE® Tissue Reinforcement for Breast Reconstruction device is intended to reinforce the soft tissue surrounding the tissue expander in preparation for the breast implant in post-mastectomy breast reconstruction
Eligibility Criteria
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Inclusion Criteria
2. First-time breast reconstruction post-mastectomy for target breast(s).
3. Scheduled to undergo unilateral or bilateral mastectomy with immediate, two-stage, implant-based, subpectoral or prepectoral breast reconstruction after mastectomy.
4. Mastectomy performed to address breast cancer or for cancer prophylaxis.
5. An informed consent form is signed by Subject or Legally Authorized Representative (LAR).
6. Subject is capable of following protocol procedures and complying with follow-up visit requirements
Exclusion Criteria
2. Subject has undergone previous radiation therapy to the reconstruction site or chest wall.
3. Subject has had chemotherapy within 3 weeks prior to the index procedure.
4. Subject has been treated for a systemic infection or local infection at the surgical site within 30 days prior to index procedure.
5. Subject has a current or previous diagnosis of Methicillin-resistant Staphylococcus aureus (MRSA).
6. Subject has a BMI \> 35.
7. Subject has a known diagnosis of diabetes with a HbA1c \> 7.0mmol/L within 30 days of the Index procedure (i.e., TE placement).
8. Subject was a current or former tobacco/nicotine user, within 90 days prior to Index Surgery (i.e., TE placement).
9. 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.
10. Subject has other medical, social, or psychological conditions which could interfere with provision of informed consent, completion of tests, therapy, or follow-up.
11. 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.
12. Subject requires a surgical technique requiring flap (autologous tissue).
13. 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
14. 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).
15. Subject receives an Acellular Dermal Matrix (ADM) or mesh that is not the TRBR Device in the target breast(s)
22 Years
FEMALE
No
Sponsors
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Avania
INDUSTRY
W.L.Gore & Associates
INDUSTRY
Responsible Party
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Principal Investigators
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Dennis Hammond, MD
Role: PRINCIPAL_INVESTIGATOR
Partners in Plastic Surgery of West Michigan
Locations
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Mayo Clinic Arizona
Scottsdale, Arizona, United States
University of Arizona
Tucson, Arizona, United States
The Regents of the University of California
Irvine, California, United States
Cedars-Sinai Plastic and Reconstruction Surgery
Los Angeles, California, United States
Riverside University Health System-Medical Center
Moreno Valley, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Endeavor Health (Northshore University HealthSystem Research Institute)
Evanston, Illinois, United States
Northwestern University
Evanston, Illinois, United States
BR Hope LLC
Wichita, Kansas, United States
The Johns Hopkins University
Baltimore, Maryland, United States
Corewell Health Research Institute
Grand Rapids, Michigan, United States
University of Mississippi
Jackson, Mississippi, United States
The Board of Regents of the University of Nebraska
Omaha, Nebraska, United States
The Joan and Sanford I. Weill Medical College of Cornell University
New York, New York, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
The Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
The University of Washington Medical Center
Seattle, Washington, United States
The Board of Regents of the University of Wisconsin System
Madison, Wisconsin, United States
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TBR 22-07
Identifier Type: -
Identifier Source: org_study_id
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