A Prospective Study of Fortiva in Hernia Repair
Launched by RTI SURGICAL · Oct 20, 2023
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility criteria
- 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
About Rti Surgical
RTI Surgical is a leading global surgical implant company dedicated to advancing the field of regenerative medicine through the development and commercialization of innovative surgical solutions. With a strong focus on biologics, orthopedic, and spinal products, RTI Surgical leverages cutting-edge research and clinical expertise to enhance patient outcomes and improve quality of life. Committed to safety and efficacy, the company actively engages in clinical trials to bring forward new therapies and technologies that address unmet medical needs in surgical procedures.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Great Yarmouth, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported