Hernia, VentralBRAVOIINCT04779918
Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh
A study testing OviTex Reinforced Tissue Matrix in people with Hernia, Ventral and Hernia, Inguinal, run by Tela Bio Inc at 10 sites in United States.
Trial summary
This study is designed to evaluate the post-operative complications and hernia recurrence following the use of OviTex in subjects with ventral or inguinal hernias. Up to 160 subjects will participate in the study from up to 20 investigator sites. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hernia, Ventral, Hernia, Inguinal
- What is being tested?
- OviTex Reinforced Tissue Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 10 sitesUnited States
- Study dates
- 29 Apr 2021to 30 Dec 2029
- Phase
- Interventional
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject suffers from a ventral or inguinal hernia that requires surgical repair with the use of an implant to reinforce or replace weakened or missing tissue.
- The patient is scheduled for an elective robotic approach with the use of OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR.
- The size of the implant needed for repair is expected to be less than or equal to 15 x 25 cm for OviTex LPR and 25 x 40 cm for OviTex Core Permanent and OviTex 1S Permanent, with no size limitation for OviTex IHR.
- Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria.
- Subject is willing and able to sign an informed consent for the study and has signed the IRB approved Informed Consent form for this study.
- Subject is able to complete Quality of Life (QoL) and pain questionnaires.
- Subject is at least 21 years old.
- Subject is willing to comply and able to participate fully in, and for the full duration of, the study including follow-up requirements.
Who cannot join
- Subject has a BMI of > 40
- Subject meets CDC/SSI Wound Classification Class IV (Dirty-Infected) criteria
- Subject is female and is pregnant or plans to become pregnant during the course of the study.
- Subject has a life expectancy of < 2 years making it unlikely that the subject will successfully achieve two-year follow-up.
- Subject has recent history of drug or alcohol abuse (in last 3 years).
- Subject has an allergy to ovine-derived products.
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- Subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial.
- Subject has a strangulated hernia.
- Subject requires implant that cannot be introduced into the surgical site during the procedure via port or an existing incision.
- Subject unable to receive OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR at time of surgery.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 3 recruiting
- Active, not recruiting
SurgOne
Denver, Colorado, 802210
- Terminated
GenesisCare
Destin, Florida, 325541
- Terminated
Surgical Healing Arts Center
Fort Myers, Florida, 33912
- Active, not recruiting
Houston Methodist
Houston, Texas, 77030
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Dajana Nenadovic, RN, 502-588-4571, dajana.nenadovic@uoflhealth.org
Farid Kehdy, MD
- Recruiting
University of South Alabama
Mobile, Alabama, 36617
Valrie Patterson, RN, 251-445-9626, valriepatterson@health.southalabama.edu
Daniel McMahon, MD
- Active, not recruiting
St. Luke's Hospital
Overland Park, Kansas, 66213
- Withdrawn
St. Francis Hospital
Roslyn, New York, 11576
- Recruiting
Munson Healthcare
Traverse City, Michigan, 49684
Kelly VanSchouwen, kelly@researchtex.com
Joel Strehl, DO
- Withdrawn
Mohawk Valley Health System
Utica, New York, 13502
About this study
Official title: A Prospective Study Evaluating the Clinical Outcomes of Ventral or Inguinal Hernias Treated Robotically With OviTex® Reinforced Tissue Matrix
This study is designed to evaluate the post-operative complications and hernia recurrence following the use of OviTex in subjects with ventral or inguinal hernias. Up to 160 subjects will participate in the study from up to 20 investigator sites.
Read the detailed description
This study is intended to evaluate the post-operative complications and recurrence following the use of OviTex in ventral or inguinal hernias being treated robotically. It is a single-arm study and all subjects will receive OviTex.
- Conditions
- Hernia, Ventral, Hernia, Inguinal
- Being tested
- OviTex Reinforced Tissue Matrix
- Keywords
- use of mesh, robotic hernia repair
- Medical subject headings
- Hernia, Ventral, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OviTex Reinforced Tissue MatrixDevice
All study subjects will receive OviTex. All OviTex Reinforced Tissue Matrices are intended for use as a surgical mesh to reinforce or repair soft tissue where weakness exists.
| Study group | Role | What they receive |
|---|---|---|
| OviTex Reinforced Tissue Matrix | Other | This is a single-arm study. All study subjects will receive OviTex. Receives: Device: OviTex Reinforced Tissue Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early surgical site occurrences or wound related events
Incidence of early peri- and post-operative surgical site occurrences or wound related events noted at the hernia repair site
Measured: occurring within the first 3 months of the ventral or inguinal hernia repair
Early post-operative complications
Incidence of other early post-operative complications
Measured: occurring within the first 3 months of the ventral or inguinal hernia repair.
Secondary outcomes (4)
Late surgical site occurrences or wound related events
Incidence of late post-operative surgical site occurrences or wound related events noted at the hernia repair site
Measured: occurring > 3 months after index surgery
Late post-operative complications
Incidence of other late post-operative complications
Measured: occurring > 3 months after index surgery.
Patient Reported Outcomes
Patient Reported Outcomes (QoL and pain assessments)
Measured: Assessed at day 30, day 90, 12 months, and 24 months post-op
Hernia Recurrence
True hernia recurrence at the site of surgery
Measured: at post-operative day 90 and months 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start29 Apr 2021
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, VentralStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tela Bio Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
- Investigators
- Geoffrey Slayden, MD, Principal investigator, St. Lukes Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779918
- Sponsor's protocol ID
- TB.2020.01.01
- Acronym
- BRAVOII
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Evaluating the Clinical Outcomes of Ventral or Inguinal Hernias Treated Robotically With OviTex® Reinforced Tissue Matrix
- ClinicalTrials.gov ID
- NCT04779918
- Acronym / sponsor ID
- BRAVOII / TB.2020.01.01
- Conditions
- Hernia, Ventral, Hernia, Inguinal
- Keywords
- use of mesh, robotic hernia repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Tela Bio IncIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 3 Mar 2021 (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.
This study is designed to evaluate the post-operative complications and hernia recurrence following the use of OviTex in subjects with ventral or inguinal hernias. Up to 160 subjects will participate in the study from up to 20 investigator sites.
Detailed description
This study is intended to evaluate the post-operative complications and recurrence following the use of OviTex in ventral or inguinal hernias being treated robotically. It is a single-arm study and all subjects will receive OviTex.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OviTex Reinforced Tissue Matrix | Other | Device: OviTex Reinforced Tissue MatrixThis is a single-arm study. All study subjects will receive OviTex. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject suffers from a ventral or inguinal hernia that requires surgical repair with the use of an implant to reinforce or replace weakened or missing tissue.
- The patient is scheduled for an elective robotic approach with the use of OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR.
- The size of the implant needed for repair is expected to be less than or equal to 15 x 25 cm for OviTex LPR and 25 x 40 cm for OviTex Core Permanent and OviTex 1S Permanent, with no size limitation for OviTex IHR.
- Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria.
- Subject is willing and able to sign an informed consent for the study and has signed the IRB approved Informed Consent form for this study.
Key exclusion criteria (10 listed)
- Subject has a BMI of > 40
- Subject meets CDC/SSI Wound Classification Class IV (Dirty-Infected) criteria
- Subject is female and is pregnant or plans to become pregnant during the course of the study.
- Subject has a life expectancy of < 2 years making it unlikely that the subject will successfully achieve two-year follow-up.
- Subject has recent history of drug or alcohol abuse (in last 3 years).
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 |
|---|---|---|
| OviTex Reinforced Tissue MatrixAll study subjects will receive OviTex. All OviTex Reinforced Tissue Matrices are intended for use as a surgical mesh to reinforce or repair soft tissue where weakness exists. | Device | OviTex Reinforced Tissue Matrix |
Primary outcome
Early surgical site occurrences or wound related events
Time frame: occurring within the first 3 months of the ventral or inguinal hernia repair
Incidence of early peri- and post-operative surgical site occurrences or wound related events noted at the hernia repair site
Early post-operative complications
Time frame: occurring within the first 3 months of the ventral or inguinal hernia repair.
Incidence of other early post-operative complications
4 secondary outcomes
Late surgical site occurrences or wound related events
Time frame: occurring > 3 months after index surgery
Late post-operative complications
Time frame: occurring > 3 months after index surgery.
Patient Reported Outcomes
Time frame: Assessed at day 30, day 90, 12 months, and 24 months post-op
Hernia Recurrence
Time frame: at post-operative day 90 and months 12 and 24
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 5 May 2026.
- 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.
Geoffrey Slayden, MD principal investigator
St. Lukes Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OviTex Reinforced Tissue Matrix in people with Hernia, Ventral and Hernia, Inguinal, run by Tela Bio Inc at 10 sites in United States.
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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
Contact Melissa LaMantia (757-761-4922, mlamantia@telabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early surgical site occurrences or wound related events (time frame: occurring within the first 3 months of the ventral or inguinal hernia repair). The study lists 2 primary outcomes in all. 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 5 May 2026.