RecruitingNot Applicable

Myriad™ Augmented Soft Tissue Reconstruction Registry

United States800 participantsStarted 2022-01-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of participants with treatment emergent adverse events during the study

Timeframe: 3 years

Trial details

NCT IDNCT05243966

SponsorAroa Biosurgery Limited

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-01

Contact for this trial

Barnaby May, PhD

+64 21 056 9995 barnaby.may@aroa.com

View on ClinicalTrials.gov More Abdominal Wound Dehiscence trials