Fortiva Hernia
Research type
Research Study
Full title
A Prospective Study of Fortiva in Hernia Repair
IRAS ID
317923
Contact name
Christopher Liao
Contact email
Sponsor organisation
RTI Surgical
Clinicaltrials.gov Identifier
NCT0610979
Duration of Study in the UK
2 years, 3 months, 2 days
Research summary
This is a post market study of a porcine acellular dermal matrix being used during hernia repair. Data is being collected to evaluate safety by review of adverse events related to the device and procedure. Performance of the device will be analyzed using self reported questionnaires completed by the patients. Patients already undergoing a hernia repair will be recruited for participation that will last for 2 years post surgery. There are no additional risks to the patient outside of the procedure they are already undergoing.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
22/PR/1350
Date of REC Opinion
5 Jan 2023
REC opinion
Further Information Favourable Opinion