Status:
ENROLLING_BY_INVITATION
A Prospective Study of Fortiva in Hernia Repair
Lead Sponsor:
RTI Surgical
Conditions:
Ventral Hernia
Incisional Hernia
Eligibility:
All Genders
18+ years
Brief 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.
Detailed Description
This is a post market, prospective, multi-center study of up to 120 participants at approximately 10 clinical study sites. Safety and performance will be measured after hernia repair for two years.
Eligibility Criteria
Inclusion
- 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
- \<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
Key Trial Info
Start Date :
November 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06101979
Start Date
November 15 2023
End Date
December 1 2027
Last Update
July 25 2025
Active Locations (1)
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1
James Paget University Hospital
Great Yarmouth, United Kingdom