By InvitationNot Applicable

A Prospective Study of Fortiva in Hernia Repair

United Kingdom120 participantsStarted 2023-11-15

Plain-language summary

The goal of this study is to evaluate safety and performance of the Fortiva Tissue Matrix. Participants will complete questionnaires to measure outcomes after hernia surgery for two years.

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: * 18 years of age at time of consent * Undergoing hernia surgery in which Fortiva Tissue Matrix will be used * Have no contraindications to the test material (s) * Able to provide informed consent * Able to read, understand and complete study questionnaires * Able and willing to return for scheduled study visits Exclusion Criteria: * \<18 years of age * American Society of Anesthesiologists (ASA) physical class of 4,5 or 6 * Currently enrolled or plans to enroll in another clinical study that would affect the validity of the study * Hernia repairs involving active infection

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

Type of adverse events

Timeframe: 6 weeks, 6 months, 12 months and 24 months

Trial details

NCT IDNCT06101979

SponsorRTI Surgical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-12

View on ClinicalTrials.gov More Ventral Hernia trials

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.