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™ — DEVICEOvine 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
- Barnaby May, PhD+64 21 056 9995
- Brandon Bosque, DMP,CWSP
Locations (13)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Surgery Group LA | Los Angeles | California | 90048 | - |
| Associates in Medicine & Surgery | Fort Myers | Florida | 33919 | - |
| Asencion Sacred Heart | Pensacola | Florida | 32504 | Kyle J. Leneweaver, DO (PRINCIPAL_INVESTIGATOR) |
| Northeast Georgia Medical Center, Inc. | Gainesville | Georgia | 30501 | William M Vassy, MD (PRINCIPAL_INVESTIGATOR) Michael T Cormican, MD (SUB_INVESTIGATOR) |
| Ochsner Baptist Medical Center | New Orleans | Louisiana | 70115 | - |
| University Medical Center | New Orleans | Louisiana | 70112 | Alison Smith, MD, PhD (PRINCIPAL_INVESTIGATOR) Frank Lau, MD (SUB_INVESTIGATOR) |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | Research Coordinator 443-220-1438 Joshua Wolf, MD (PRINCIPAL_INVESTIGATOR) |
| Nuvance Health Vassar Brothers Medical Center | Poughkeepsie | New York | 12601 | - |
| Moses H Cone Memorial Hospital Operating Corporation | Greensboro | North Carolina | 27401-1004 | - |
| Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | - |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17601 | Lindsey Perea, DO (PRINCIPAL_INVESTIGATOR) |
| Tower Health Reading Hospital | West Reading | Pennsylvania | 19611 | - |
| The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Jacob Peschman, MD 414-955-1751 |
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