A Prospective Study of Fortiva in Hernia Repair

July 24, 2025 updated by: RTI Surgical
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Great Yarmouth, United Kingdom
        • James Paget University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be candidates for hernia surgery recruited from the participating Investigator's population

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fortiva Tissue Matrix
Device: Fortiva Tissue Matrix
Acellular Dermal Matrix used in hernia surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Type of adverse events
Time Frame: 6 weeks, 6 months, 12 months and 24 months
6 weeks, 6 months, 12 months and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant failure
Time Frame: 6 weeks, 6 months, 12 months and 24 months
Partial or total removal of Fortiva Tissue Matrix
6 weeks, 6 months, 12 months and 24 months
Hernia recurrence
Time Frame: 12 months
Hernia recurrence requiring surgical reintervention
12 months
Patient satisfaction
Time Frame: 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
6 weeks, 6 months, 12 months and 24 months
Pain measured using the visual analog scale for pain
Time Frame: 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
6 weeks, 6 months, 12 months and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RTI Surgical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2025

Last Update Submitted That Met QC Criteria

July 24, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTI-2022-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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