Registry for soft tissue reconstruction using Myriad™ devices
Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures
This study is testing how safe and effective Myriad Matrix™ and Morcells™ devices are for people undergoing soft tissue reconstruction surgeries for different conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aroa Biosurgery Limited Industry-sponsored |
| Locations | 13 sites (Los Angeles, California and 12 other locations) |
| Trial ID | NCT05243966 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and clinical outcomes of Myriad Matrix™ and Morcells™ in various soft tissue reconstruction procedures. Participants will be enrolled from multiple centers and will undergo surgical interventions where these devices are utilized as part of standard care. The study aims to gather data on a range of conditions, including abdominal wound dehiscence and necrotizing soft tissue infections, to assess the effectiveness of these treatments in real-world settings.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing soft tissue reconstruction procedures involving Myriad Matrix™ or Morcells™.
Not a fit: Patients with known sensitivities to ovine-derived materials or those with uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of soft tissue reconstruction outcomes, potentially leading to improved surgical practices and patient recovery.
How similar studies have performed: While this approach is observational, similar studies using advanced soft tissue reconstruction techniques have shown promising outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Willing and able to provide written informed consent and to comply with the requirements of Clinical Investigational Plan
* Male or female patients aged 18 years or above
* Patients where Matrix and/or Morcells were used as part of their soft tissue reconstruction procedure
* Subject that are willing and able to comply with all aspects of the treatment and evaluation schedule
Exclusion Criteria:
* Patients with known sensitivity to ovine (sheep) derived material
* Patients with full thickness ('third degree') burns
* Patients with wounds with uncontrolled clinical infection (CDC Contamination Grade=4)
* Any medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the patient to participate in the study
* Patient is currently participating or has participated in another clinical study within past 30 days prior to enrollment
* Pregnant or lactating women
* Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study
Where this trial is running
Los Angeles, California and 12 other locations
- Surgery Group LA — Los Angeles, California, United States (Completed)
- Associates in Medicine & Surgery — Fort Myers, Florida, United States (Active_not_recruiting)
- Asencion Sacred Heart — Pensacola, Florida, United States (Recruiting)
- Northeast Georgia Medical Center, Inc. — Gainesville, Georgia, United States (Recruiting)
- University Medical Center — New Orleans, Louisiana, United States (Recruiting)
- Ochsner Baptist Medical Center — New Orleans, Louisiana, United States (Enrolling_by_invitation)
- Sinai Hospital of Baltimore — Baltimore, Maryland, United States (Recruiting)
- Nuvance Health Vassar Brothers Medical Center — Poughkeepsie, New York, United States (Enrolling_by_invitation)
- Moses H Cone Memorial Hospital Operating Corporation — Greensboro, North Carolina, United States (Enrolling_by_invitation)
- Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Enrolling_by_invitation)
- Lancaster General Hospital — Lancaster, Pennsylvania, United States (Recruiting)
- Tower Health Reading Hospital — West Reading, Pennsylvania, United States (Enrolling_by_invitation)
- The Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Barnaby May, PhD
- Email: barnaby.may@aroa.com
- Phone: +64 21 056 9995
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.