NCT05243966 Myriad™ Augmented Soft Tissue Reconstruction Registry
| NCT ID | NCT05243966 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aroa Biosurgery Limited |
| Condition | Abdominal Wound Dehiscence |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2022-01-10 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2022-01-10 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Tracee Short, MD
STUDY CHAIR
Short Consulting Group, LLC
Frequently Asked Questions
Who can join the NCT05243966 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Abdominal Wound Dehiscence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05243966 currently recruiting?
Yes, NCT05243966 is actively recruiting participants. Contact the research team at barnaby.may@aroa.com for enrollment information.
Where is the NCT05243966 trial being conducted?
This trial is being conducted at Los Angeles, United States, Fort Myers, United States, Pensacola, United States, Gainesville, United States and 9 additional locations.
Who is sponsoring the NCT05243966 clinical trial?
NCT05243966 is sponsored by Aroa Biosurgery Limited. The principal investigator is Tracee Short, MD at Short Consulting Group, LLC. The trial plans to enroll 800 participants.