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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 22
- 主要终点
- Absence of device- or procedure-related major adverse events (MAEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 >
- •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)
研究组 & 干预措施
Prospective Arm
Prospectively treated subjects who undergo two-stage implant-based breast reconstruction with the TRBR Device (TRBR Device group)
干预措施: TRBR Device (Device)
结局指标
主要结局
Absence of device- or procedure-related major adverse events (MAEs)
时间窗: 1 year post index procedure
Require rehospitalization or reoperation
次要结局
- BREAST-Q Physical Well Being(1-year post-index procedure.)