A Prospective Study of Fortiva in Hernia Repair

• Conditions: Ventral Hernia; Abdominal Wall Reconstruction; Incisional Hernia
• Interventions: Device: Fortiva Tissue Matrix

• Registration Number: NCT06101979
• Lead Sponsor: RTI Surgical

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.

Study Timeline

• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-20
• Study First Posted: 2023-10-26
• Study Start: 2023-11-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fortiva Tissue Matrix	Fortiva Tissue Matrix	-

Primary Outcome Measures

Name	Time	Method
Type of adverse events	6 weeks, 6 months, 12 months and 24 months

Secondary Outcome Measures

Name	Time	Method
Hernia recurrence	12 months	Hernia recurrence requiring surgical reintervention
Pain measured using the visual analog scale for pain	6 weeks, 6 months, 12 months and 24 months	Visual Analog Scale using a scale of 0-10 with 0 being no pain and 10 being unbearable pain
Implant failure	6 weeks, 6 months, 12 months and 24 months	Partial or total removal of Fortiva Tissue Matrix
Patient satisfaction	6 weeks, 6 months, 12 months and 24 months	SF-36 questionnaire has 8 multi-item scales with a higher score representing better health status. Each domain has a score range of 0-100

Trial Locations

Locations (1)

James Paget University Hospital; 🇬🇧 Great Yarmouth, United Kingdom