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Melodi Matrix™ in Breast Reconstruction

Melodi Health, Inc. · NCT06027996

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22+ · Women only
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
702
US sites recruiting
10
Study start
August 9, 2024
Record last updated
December 8, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Absorbable Antibacterial Matrix

Conditions: Breast Reconstruction

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 Criteria

  • 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.

Recruiting US locations

  • Stanford University

    Palo Alto, CA 94304

    Site contact: Elizabeth Tadevosyan · 818-269-1950 · etadyan@stanford.edu

  • University of Michigan Health

    Ann Arbor, MI 48109

    Site contact: Jenni Hamill · 507-559-7912 · jenberry@umich.edu

  • Mayo Clinic

    Rochester, MN 55905

    Site contact: Amy Holst · 507-538-4849 · BMSORESEARCH@mayo.edu

  • Northwell Health

    Staten Island, NY 10305

    Site contact: Shannen Ballotte · 718-226-8559 · sbelotte@northwell.edu

  • The Ohio State University

    Columbus, OH 43212

    Site contact: Jenna King · 614-293-7551 · cody11@osumc.edu

  • UPMC

    Pittsburgh, PA 15213

    Site contact: Eleanor Shirley · 412-624-2376 · shirleye@upmc.edu

  • Medical University of South Carolina

    Charleston, SC 29425

    Site contact: Deanna DeHoff · 843-792-8522 · dehoff@musc.edu

  • Monument Health

    Rapid City, SD 57701

    Site contact: Angie Dunbar · 605-755-2370 · adunbar@monument.health

  • MD Anderson Cancer Center

    Houston, TX 77030

    Site contact: Sara Hull · 832-499-6321 · sehull@mdanderson.org

  • University of Utah

    Salt Lake City, UT 84112

    Site contact: Martin Carricaburu · 801-581-3363

Study contacts (from the official record)

  • Michele Hilmer · 210-279-0194 · michele.hilmer@melodihealth.com
Melodi Matrix™ in Breast Reconstruction (NCT06027996) | Bored Studies