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)
View Full Details on ClinicalTrials.gov
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NCT05243966
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