Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)

Официальное название

Evaluation of the Safety and Effectiveness of the GORE® Tissue Reinforcement for Breast Reconstruction Device (TRBR Device) When Used in the Reinforcement of Breast Reconstruction

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Absence of device- or procedure-related major adverse events (MAEs) [Срок оценки: 1 year post index procedure]

Вторичные конечные точки (1)

• BREAST-Q Physical Well Being [Срок оценки: 1-year post-index procedure.]

Критерии участия

Критерии включения

• 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

Критерии исключения

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 20 центров

• Mayo Clinic Arizona — Scottsdale
• University of Arizona — Tucson
• The Regents of the University of California — Irvine
• Cedars-Sinai Plastic and Reconstruction Surgery — Los Angeles
• Riverside University Health System-Medical Center — Moreno Valley
• Mayo Clinic Florida — Jacksonville
• Endeavor Health (Northshore University HealthSystem Research Institute) — Evanston
• Northwestern University — Evanston
• … и ещё 12 центров

Идентификаторы

NCT: NCT06556654 · TBR 22-07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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