Acellular Dermal Matrix Investigation in Breast Reconstruction

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
RTI Surgical
Study ID
NCT06456554
Status
Recruiting
Apply to this trial

Conditions

  • Breast Reconstruction

Eligibility Criteria

Sex
FEMALE
Age
22 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Acellular Dermal Matrix (Cortiva Tissue Matrix) — DEVICE
    non-crosslinked dermis

Study Details

Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.

Key Dates

Start date
Nov 22, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
467 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Acellular Dermal Matrix
    Breast reconstruction with Cortiva Tissue Matrix
  • No Intervention: no Acellular Dermal Matrix
    Breast reconstruction only with no ADM

Primary Outcome Measure

Rate of major adverse events [ Time Frame: 12 months ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
University of ArkansasLittle RockArkansas72205-
City of Hope National Medical CenterDuarteCalifornia91010
Shalini Shah
University of ColoradoAuroraColorado80045
Mamadou Seye
[email protected]
Christodoulos Kaoutzanis, MD (PRINCIPAL_INVESTIGATOR)
University of KansasLawrenceKansas66045
Jessica Reynolds
[email protected]
619-753-2866
Mercy HospitalSt LouisMissouri63141
Brenna Reilly
[email protected]
Michael Curtis, MD (PRINCIPAL_INVESTIGATOR)
Washington UniversitySt LouisMissouri63110
Aliyah Thomas
[email protected]
Trina Ebersole, MD (PRINCIPAL_INVESTIGATOR)
New York Presbyterian Hospital/Columbia University Irving Medical CenterNew YorkNew York10032
Ken Watanabe
[email protected]
Camila Boneu
[email protected]
Christine Rohde, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Brooke Miller
[email protected]
Nolan Karp, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Risal Djohan, MD (PRINCIPAL_INVESTIGATOR)
MercyOklahoma CityOklahoma73120
Maryann Martinovic, MD
[email protected]
(405) 749-7023
Mercy HospitalOklahoma CityOklahoma73120
Maryann Martinovic, MD
University of PennsylvaniaPhiladelphiaPennsylvania19104
Robyn Broach, PhD
[email protected]
Jessica Rose, DO (PRINCIPAL_INVESTIGATOR)
MD AndersonHoustonTexas77030
Sara Hull
[email protected]
713-500-2000

Find similar trials in Little Rock, AR

By research site
University of Arkansas· Little Rock, ARCity of Hope National Medical Center· Duarte, CAUniversity of Colorado· Aurora, COUniversity of Kansas· Lawrence, KSMercy Hospital· St Louis, MOWashington University· St Louis, MO

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