A Prospective Study of Fortiva in Hernia Repair

NCT ID: NCT06101979

Last Updated: 2025-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-15

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Ventral Hernia Incisional Hernia Abdominal Wall Reconstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fortiva Tissue Matrix

Fortiva Tissue Matrix

Intervention Type DEVICE

Acellular Dermal Matrix used in hernia surgery

Interventions

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Fortiva Tissue Matrix

Acellular Dermal Matrix used in hernia surgery

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RTI Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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James Paget University Hospital

Great Yarmouth, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RTI-2022-01

Identifier Type: -

Identifier Source: org_study_id

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