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 range18 Years

SexALL

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

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