Myriad™ Augmented Soft Tissue Reconstruction Registry

Part of paid clinical trials in Los Angeles, California.

Sponsor
Aroa Biosurgery Limited
Study ID
NCT05243966
Status
Recruiting

Conditions

  • Abdominal Wound Dehiscence
  • Anal Fistula
  • Hidradenitis Suppurativa
  • Lower Extremity Wound
  • Necrotizing Soft Tissue Infection
  • Pilonidal Sinus
  • Pressure Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Myriad Matrix™ and Myriad Morcells™ — DEVICE
    Ovine forestomach matrix sheet graft and morselized extracellular matrix

Study Details

This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures. The study will enroll participants who are undergoing a surgical procedure, where the attending physician will use Myriad™ as part of the surgical intervention.

Key Dates

Start date
Jan 10, 2022
Status verified
Jan 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
800 participants (estimated)

Arms

  • Arm: Myriad™
    Ovine forestomach matrix sheet graft and morselized extracellular matrix

Primary Outcome Measure

Proportion of participants with treatment emergent adverse events during the study [ Time Frame: 3 years ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Surgery Group LALos AngelesCalifornia90048-
Associates in Medicine & SurgeryFort MyersFlorida33919-
Asencion Sacred HeartPensacolaFlorida32504
Kymberly Palmer
813-843-1398
Kyle J. Leneweaver, DO (PRINCIPAL_INVESTIGATOR)
Northeast Georgia Medical Center, Inc.GainesvilleGeorgia30501
Emily Murdoch
(770)-219-3438
William M Vassy, MD (PRINCIPAL_INVESTIGATOR)
Michael T Cormican, MD (SUB_INVESTIGATOR)
Ochsner Baptist Medical CenterNew OrleansLouisiana70115-
University Medical CenterNew OrleansLouisiana70112
Alison Smith, MD, PhD
504-903-9009
Frank Lau, MD
504-412-1240
Alison Smith, MD, PhD (PRINCIPAL_INVESTIGATOR)
Frank Lau, MD (SUB_INVESTIGATOR)
Sinai Hospital of BaltimoreBaltimoreMaryland21215
Research Coordinator
443-220-1438
Joshua Wolf, MD (PRINCIPAL_INVESTIGATOR)
Nuvance Health Vassar Brothers Medical CenterPoughkeepsieNew York12601-
Moses H Cone Memorial Hospital Operating CorporationGreensboroNorth Carolina27401-1004-
Ohio State University Wexner Medical CenterColumbusOhio43210-
Lancaster General HospitalLancasterPennsylvania17601
Medoza Ameen
223-221-1177
Lindsey Perea, DO (PRINCIPAL_INVESTIGATOR)
Tower Health Reading HospitalWest ReadingPennsylvania19611-
The Medical College of WisconsinMilwaukeeWisconsin53226
Thomas Carver, MD
414-955-1751
Jacob Peschman, MD
414-955-1751

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