Safety and Effectiveness of the TRBR Device in Breast Reconstruction

What is the Purpose of this Study?

Primary endpoint Absence of device- or procedure-related major adverse events (MAEs) which require rehospitalization or reoperation through 1-year Post-Index Surgery (i.e., tissue expander implantation with or without the TRBR Device). Secondary endpoints ? BREAST-Q Physical Well Being, Chest Score change from baseline (Pre-Index Surgery) at 1-year Post-Index Surgery (Treatment Arm only). ? Absence of device- or procedure-related MAEs which require rehospitalization or reoperation through 1-year Post-Index Surgery due to adverse event; this excludes wound infections requiring oral or IV antibiotics. Other parameters ? Absence of device- or procedure-related MAEs which require rehospitalization or reoperation through 2-year and 3-year Post-Index Surgery due to adverse event; this excludes wound infections requiring oral or IV antibiotics (Treatment Arm only). ? Absence of device- or procedure-related MAEs which require rehospitalization or reoperation through 2-year and 3-year Post-Index Surgery (i.e., tissue expander implantation with or without the TRBR Device) (Treatment Arm only). ? BREAST-Q Physical Well Being, Chest Score at 1-year, 2-year, and 3-year Post-Index Surgery which is greater than or equal to (-4) points of baseline (Pre-Index Surgery) score (Treatment Arm only). ? BREAST-Q Physical Well Being, Chest Score at 2-year and 3-year Post-Index Surgery (Treatment Arm only). ? BREAST-Q Satisfaction with Breast at 1-year, 2-year, and 3-year Post-Index Surgery (Treatment Arm only). ? Breast tissue expander fill volume (Treatment Arm only). ? Breast tissue expander fill time (from time of initial fill to complete fill) (Treatment Arm only). ? Absence of Tissue Expander explantation without replacement or exchange to permanent implant through 1-year, 2-year and 3-year Post-Index Surgery for Treatment Arm and through 1-year Post-Index Surgery for Historical Control Arm. ? Absence of permanent implant explantation without replacement through 1-year, 2-year and 3-year Post-Index Surgery for Treatment Arm and through 1-year Post-Index Surgery for Historical Control Arm. ? Incidence of Adverse Events (TRBR Device): summary of all reported adverse events during the study (Treatment Arm only). ? EQ-5D-5L QoL at baseline, 1-year, 2-year, and 3-year Post-Index Surgery follow-up (Treatment Arm only). ? Subject-reported Systemic Symptoms at baseline, Exchange Surgery, 1-year, 2-year, and 3-year follow-up and at permanent implant removal if not replaced (Treatment Arm only). Note: All safety data will be collected throughout the study. The adverse events are not limited to device-related adverse events.

Eligibility

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.

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:

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)

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

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

Study Details

Disease Type/Condition

Other

Principal Investigator

McCullough, Meghan

Age Group

Adult

Phase

N/A

IRB Number

STUDY00004333

ClinicalTrials.gov ID

NCT06556654

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org