A Prospective Study of Fortiva in Hernia Repair | NCT06101979

Studies
A Prospective Study of Fortiva in Hernia Repair

NCT06101979

Sponsor

RTI Surgical

Status

Enrolling by invitation

Last Update Posted

Jul 25, 2025Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Ventral Hernia
Incisional Hernia
Abdominal Wall Reconstruction

Interventions

Fortiva Tissue Matrix

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2023Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Oct 20, 2023

First Submission Date that Met QC Criteria

Oct 20, 2023

First Posted Date

Oct 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2025

Last Update Posted Date

Jul 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fortiva Tissue Matrix			Device: Fortiva Tissue Matrix

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fortiva Tissue Matrix	Device	Acellular Dermal Matrix used in hernia surgery	Fortiva Tissue Matrix

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Patient satisfaction	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
James Paget University Hospital		Great Yarmouth			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006555	Hernia, Ventral
D000069290	Incisional Hernia

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided