RecruitingNCT05243966

Myriad™ Augmented Soft Tissue Reconstruction Registry

Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures


Sponsor

Aroa Biosurgery Limited

Enrollment

800 participants

Start Date

Jan 10, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

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Interventions

DEVICEMyriad Matrix™ and Myriad Morcells™

Ovine forestomach matrix sheet graft and morselized extracellular matrix


Locations(13)

Surgery Group LA

Los Angeles, California, United States

Associates in Medicine & Surgery

Fort Myers, Florida, United States

Asencion Sacred Heart

Pensacola, Florida, United States

Northeast Georgia Medical Center, Inc.

Gainesville, Georgia, United States

University Medical Center

New Orleans, Louisiana, United States

Ochsner Baptist Medical Center

New Orleans, Louisiana, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Nuvance Health Vassar Brothers Medical Center

Poughkeepsie, New York, United States

Moses H Cone Memorial Hospital Operating Corporation

Greensboro, North Carolina, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Tower Health Reading Hospital

West Reading, Pennsylvania, United States

The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05243966


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