A Prospective Study of Fortiva in Hernia Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fortiva Tissue Matrix.
- Who it may be relevant to
- Registry conditions: Ventral Hernia, Incisional Hernia, Abdominal Wall Reconstruction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Fortiva Tissue Matrix
Acellular Dermal Matrix used in hernia surgery
Primary outcome measures
- Type of adverse events [Time frame: 6 weeks, 6 months, 12 months and 24 months]
Secondary outcome measures (4)
- Patient satisfaction [Time frame: 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]
- Implant failure [Time frame: 6 weeks, 6 months, 12 months and 24 months]
- Hernia recurrence [Time frame: 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- James Paget University Hospital — Great Yarmouth
Identifiers
NCT: NCT06101979 · RTI-2022-01