NCT06101979

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Nov 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Nov 2023Dec 2027

First Submitted

Initial submission to the registry

October 20, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

4 years

First QC Date

October 20, 2023

Last Update Submit

July 24, 2025

Conditions

Ventral HerniaIncisional HerniaAbdominal Wall Reconstruction

Outcome Measures

Primary Outcomes (1)

  • Type of adverse events

    6 weeks, 6 months, 12 months and 24 months

Secondary Outcomes (4)

  • Patient satisfaction

    6 weeks, 6 months, 12 months and 24 months

  • Pain measured using the visual analog scale for pain

    6 weeks, 6 months, 12 months and 24 months

  • Implant failure

    6 weeks, 6 months, 12 months and 24 months

  • Hernia recurrence

    12 months

Study Arms (1)

Fortiva Tissue Matrix

Device: Fortiva Tissue Matrix

Interventions

Fortiva Tissue MatrixDEVICE

Acellular Dermal Matrix used in hernia surgery

Fortiva Tissue Matrix

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James Paget University Hospital

Great Yarmouth, United Kingdom

Location

MeSH Terms

Conditions

Hernia, VentralIncisional Hernia

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2023

First Posted

October 26, 2023

Study Start

November 15, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

July 25, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)