A Prospective Study of Fortiva in Hernia Repair

Launched by RTI SURGICAL · Oct 20, 2023

Keywords

ClinConnect Summary

This is a post-market, forward-looking study to see how safe and how well the Fortiva Tissue Matrix works when used in hernia repair. It will follow up to 120 adults at about 10 sites (including a hospital in the United Kingdom) for two years after surgery. Researchers will track any safety issues and also how patients feel about their recovery and overall health over time.

Who can join: adults 18 or older who are having hernia surgery where Fortiva Tissue Matrix will be used, and who can give informed consent and complete follow-up questionnaires. People with very high surgical risk (ASA class 4–6), those participating in other conflicting trials, or repairs with active infection are not eligible. Participants will complete visits and questionnaires at about 6 weeks, 6 months, 12 months, and 24 months after surgery. The questionnaires cover pain (rated 0–10), overall health and satisfaction (a health questionnaire where higher scores mean better health, 0–100), and checks for implant problems or hernia recurrence requiring another operation. The study is led by RTI Surgical and is currently enrolling in the UK, with completion anticipated in 2027. No study results are available yet.

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