Melodi Matrix™ in Breast Reconstruction

Part of paid clinical trials in Palo Alto, California.

Sponsor
Melodi Health, Inc.
Study ID
NCT06027996
Status
Recruiting
Apply to this trial

Conditions

  • Breast Reconstruction

Eligibility Criteria

Sex
FEMALE
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Absorbable Antibacterial Matrix — DEVICE
    Soft tissue support coated with antibiotics

Study Details

Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.

Key Dates

Start date
Aug 9, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
702 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Treatment
    Tissue expander implantation with the Melodi Matrix
  • No Intervention: Control
    Tissue expander implantation without a matrix

Primary Outcome Measure

Complications of Breast Reconstruction [ Time Frame: 6 months ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Elizabeth Tadevosyan
[email protected]
818-269-1950
University of Michigan HealthAnn ArborMichigan48109
Jenni Hamill
[email protected]
507-559-7912
Mayo ClinicRochesterMinnesota55905
Amy Holst
[email protected]
507-538-4849
Northwell HealthStaten IslandNew York10305
Shannen Ballotte
[email protected]
718-226-8559
The Ohio State UniversityColumbusOhio43212
Jenna King
[email protected]
614-293-7551
UPMCPittsburghPennsylvania15213
Eleanor Shirley
[email protected]
412-624-2376
Medical University of South CarolinaCharlestonSouth Carolina29425
Deanna DeHoff
[email protected]
843-792-8522
Monument HealthRapid CitySouth Dakota57701
Angie Dunbar
[email protected]
605-755-2370
MD Anderson Cancer CenterHoustonTexas77030
Sara Hull
[email protected]
832-499-6321
University of UtahSalt Lake CityUtah84112
Martin Carricaburu
801-581-3363

Find similar trials in Palo Alto, CA

By research site
Stanford University· Palo Alto, CAUniversity of Michigan Health· Ann Arbor, MIMayo Clinic· Rochester, MNNorthwell Health· Staten Island, NYThe Ohio State University· Columbus, OHUPMC· Pittsburgh, PA

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