Status:
RECRUITING
Melodi Matrix™ in Breast Reconstruction
Lead Sponsor:
Melodi Health, Inc.
Conditions:
Breast Reconstruction
Eligibility:
FEMALE
22+ years
Phase:
NA
Brief Summary
Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.
Eligibility Criteria
Inclusion
- Female.
- Age 22 or older at the time of enrollment.
- Is scheduled to undergo unilateral or bilateral mastectomy (including prophylactic) with immediate two-stage post-mastectomy alloplastic prepectoral breast reconstruction.
- Is able to and willing to comply with the study requirements and providing informed consent.
Exclusion
- Has prior history of neoadjuvant radiotherapy.
- Has had prior history of failed tissue expansion or breast implantation at the intended reconstruction site.
- Has an active abscess or infection requiring antibiotics anywhere in their body within 30 days.
- Has a Body Mass Index (BMI) \< 14 or \> 40.
- Is pregnant or is nursing; or plans to become pregnant during the course of the study.
- Has any connective tissue/autoimmune disorder or rheumatoid disease.
- Has known allergies to study device materials.
- Is participating in another interventional research study that may interfere with study endpoints.
- Has limited life expectancy or co-morbid conditions, social/psychological problems, or cognitive impairments that precludes participation.
- Has a medical condition or is taking medications that would result in elevated risk and/or affect the validity of the study.
- Intraoperative assessment demonstrates unfavorable conditions (i.e., poor mastectomy skin flap thickness or viability) for immediate, two-stage post-mastectomy alloplastic prepectoral reconstruction in any breast.
Key Trial Info
Start Date :
August 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
702 Patients enrolled
Trial Details
Trial ID
NCT06027996
Start Date
August 9 2024
End Date
June 1 2028
Last Update
December 8 2025
Active Locations (10)
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1
Stanford University
Palo Alto, California, United States, 94304
2
University of Michigan Health
Ann Arbor, Michigan, United States, 48109
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
4
Northwell Health
Staten Island, New York, United States, 10305