Ventral HerniaNCT06101979
A Prospective Study of Fortiva in Hernia Repair
An observational study of Ventral Hernia and Incisional Hernia, run by RTI Surgical at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia, Incisional Hernia, Abdominal Wall Reconstruction
- What is being tested?
- Fortiva Tissue Matrix
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Nov 2023to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be candidates for hernia surgery recruited from the participating Investigator's population
Who may be able to join
- 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
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Being tested
- Fortiva Tissue Matrix
- Medical subject headings
- Hernia, Ventral, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortiva Tissue MatrixDevice
Acellular Dermal Matrix used in hernia surgery
| Study group | Role | What they receive |
|---|---|---|
| Fortiva Tissue Matrix | Not described Receives: Device: Fortiva Tissue Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of adverse events
Measured: 6 weeks, 6 months, 12 months and 24 months
Secondary outcomes (4)
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
Measured: 6 weeks, 6 months, 12 months and 24 months
Pain measured using the visual analog scale for pain
Visual Analog Scale using a scale of 0-10 with 0 being no pain and 10 being unbearable pain
Measured: 6 weeks, 6 months, 12 months and 24 months
Implant failure
Partial or total removal of Fortiva Tissue Matrix
Measured: 6 weeks, 6 months, 12 months and 24 months
Hernia recurrence
Hernia recurrence requiring surgical reintervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start15 Nov 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTI Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101979
- Sponsor's protocol ID
- RTI-2022-01
- Status last verified
- Jul 2025
- First submitted
- 20 Oct 2023
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Fortiva in Hernia Repair
- ClinicalTrials.gov ID
- NCT06101979
- Acronym / sponsor ID
- RTI-2022-01
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- RTI SurgicalIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fortiva Tissue Matrix | – | Device: Fortiva Tissue Matrix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be candidates for hernia surgery recruited from the participating Investigator's population
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fortiva Tissue MatrixAcellular Dermal Matrix used in hernia surgery | Device | Fortiva Tissue Matrix |
Primary outcome
Type of adverse events
Time frame: 6 weeks, 6 months, 12 months and 24 months
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventral Hernia and Incisional Hernia, run by RTI Surgical at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of adverse events (time frame: 6 weeks, 6 months, 12 months and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.