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New treatment option for Mastectomy
Official title Assessment of the Interi Manifold in Implant-Based Breast Reconstruction
ClinicalTrials.gov ID: NCT05975359
What this study is testing
- What it's testing
- Patients with breast cancer that elect to undergo implant-based breast reconstruction (IBBR) often require the placement of a surgical drain. Surgical drains are used to manage dead space and prevent seroma formation or accumulation of fluid within the surgical field postoperatively.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65, women only
You may be able to join if
- Breast cancer diagnosis (any form) or Genetic mutation with presence of breast mass.
- Indication for bilateral mastectomy
- Plan for immediate, implant-based pre-pectoral breast reconstruction using an acellular dermal matrix
- Age 18 - 65
- Female Sex
You likely can't join if
- Have a prior history of radiation to the breast or planned radiotherapy to the breast within the first year post-operatively.
- Are enrolled in another study that requires the concomitant use of any investigational product during the study period that the Principal...
- Have received oncologic chemotherapy within the past 21 days or planned within the time fame of the study intervention. Have received antiplatelet...
- Are a smoker or use illicit drugs.
- Any prior allergic reaction to Teflon.
- Are pregnant or nursing.
See the full eligibility criteria
- Breast cancer diagnosis (any form) or Genetic mutation with presence of breast mass.
- Indication for bilateral mastectomy
- Plan for immediate, implant-based pre-pectoral breast reconstruction using an acellular dermal matrix
- Age 18 - 65
- Female Sex
- Ability to understand and the willingness to personally sign the written IRB-approved informed consent document (English language).
- Have a prior history of radiation to the breast or planned radiotherapy to the breast within the first year post-operatively.
- Are enrolled in another study that requires the concomitant use of any investigational product during the study period that the Principal Investigator believes will interfere with study endpoints.
- Have received oncologic chemotherapy within the past 21 days or planned within the time fame of the study intervention. Have received antiplatelet therapy (other than aspirin) and/ or other anticoagulation therapy in...
- Are a smoker or use illicit drugs.
- Any prior allergic reaction to Teflon.
- Are pregnant or nursing.
- Are undergoing a delayed reconstruction following mastectomy.
- HIV infection, active UTI infection, or other active infection.
- Those requiring more than one Manifold for fluid removal per breast will be excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, 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, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States. 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.