NCT06556654 Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
| NCT ID | NCT06556654 |
| Status | Recruiting |
| Phase | — |
| Sponsor | W.L.Gore & Associates |
| Condition | Breast Reconstruction Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-04-09 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2025-04-09 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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.
Eligibility Criteria
Inclusion Criteria: 1. Female subjects ≥ 22 years of age. 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: Baseline Exclusion Criteria 1. Subject has had a revision(s) in the target breast(s) following complications of breast augmentation, mastopexy (breast lift), or breast reduction. 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)
Contact & Investigator
Dennis Hammond, MD
PRINCIPAL INVESTIGATOR
Partners in Plastic Surgery of West Michigan
Frequently Asked Questions
Who can join the NCT06556654 clinical trial?
This trial is open to female participants only, aged 22 Years or older, studying Breast Reconstruction Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06556654 currently recruiting?
Yes, NCT06556654 is actively recruiting participants. Contact the research team at TBR22-07@wlgore.com for enrollment information.
Where is the NCT06556654 trial being conducted?
This trial is being conducted at Scottsdale, United States, Tucson, United States, Irvine, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT06556654 clinical trial?
NCT06556654 is sponsored by W.L.Gore & Associates. The principal investigator is Dennis Hammond, MD at Partners in Plastic Surgery of West Michigan. The trial plans to enroll 180 participants.