New device for breast reconstruction after mastectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of a new medical device, the Tissue Reinforcement for Breast Reconstruction (TRBR) Device, during breast reconstruction surgeries following mastectomy. Participants will be divided into two groups: one receiving the TRBR Device and the other serving as a control group who have undergone similar surgeries without the device. The study aims to assess the safety and effectiveness of the TRBR Device in improving breast reconstruction outcomes. Data collected will be compared between the two groups to evaluate the potential benefits of the device.

Why it matters

Who can join: the full rules

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)

Where it's running

• Mayo Clinic Arizona
  Scottsdale, Arizona, United States Recruiting
• University of Arizona
  Tucson, Arizona, United States Recruiting
• Riverside University Health System-Medical Center
  Moreno Valley, California, United States Recruiting
• Mayo Clinic Florida
  Jacksonville, Florida, United States Recruiting
• Endeavor Health (Northshore University HealthSystem Research Institute)
  Evanston, Illinois, United States Recruiting
• Northwestern University
  Evanston, Illinois, United States Recruiting

Study contacts

• Principal investigator: Dennis Hammond, MD — Partners in Plastic Surgery of West Michigan
• Study coordinator: Ariana O'Neill
• Email: TBR22-07@wlgore.com
• Phone: 1 800-437-8181

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.