Status:
RECRUITING
Assessment of the Interi Manifold in Implant-Based Breast Reconstruction
Lead Sponsor:
Stanford University
Collaborating Sponsors:
IC Surgical, Inc.
Conditions:
Mastectomy
Implant Based Breast Reconstruction
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Patients seeking a mastectomy with immediate tissue expander/implant-based breast reconstruction will be considered. Potential participants will be screened for inclusion and exclusion criteria and in...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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 the past 60 days.
- 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.
Key Trial Info
Start Date :
October 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05975359
Start Date
October 5 2023
End Date
March 1 2026
Last Update
November 20 2025
Active Locations (1)
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1
Stanford Hospital and Clinics
Palo Alto, California, United States, 94304