BridgeMD
New treatment option for Breast Reconstruction Surgery
Official title Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
ClinicalTrials.gov ID: NCT06556654
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older, women only
You may be able to join if
- Female people ≥ 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...
- Mastectomy performed to address breast cancer or for cancer prophylaxis.
- An informed consent form is signed by Subject or Legally Authorized Representative (LAR).
You likely can't join if
- 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).
See the full eligibility criteria
- Female people ≥ 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
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Moreno Valley, California, United States
- Jacksonville, Florida, United States
- Evanston, Illinois, United States
- Wichita, Kansas, United States
- Baltimore, Maryland, United States
- Grand Rapids, Michigan, United States
- Jackson, Mississippi, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Seattle, Washington, United States
- Madison, Wisconsin, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Tucson, Arizona, United States; Irvine, California, United States; Los Angeles, California, United States; Moreno Valley, California, United States; Jacksonville, Florida, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.