Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh (BRAVOII)

April 29, 2026 updated by: Tela Bio Inc

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36617
    • Colorado
      • Denver, Colorado, United States, 802210
        • Active, not recruiting
        • SurgOne
    • Florida
      • Destin, Florida, United States, 325541
        • Terminated
        • Genesiscare
      • Fort Myers, Florida, United States, 33912
        • Terminated
        • Surgical Healing Arts Center
    • Kansas
      • Overland Park, Kansas, United States, 66213
        • Active, not recruiting
        • St. Luke's Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville
        • Principal Investigator:
          • Farid Kehdy, MD
        • Contact:
    • Michigan
      • Traverse City, Michigan, United States, 49684
        • Recruiting
        • Munson Healthcare
        • Contact:
        • Principal Investigator:
          • Joel Strehl, DO
    • New York
      • Roslyn, New York, United States, 11576
        • Withdrawn
        • St. Francis Hospital
      • Utica, New York, United States, 13502
        • Withdrawn
        • Mohawk Valley Health System
    • Texas
      • Houston, Texas, United States, 77030
        • Active, not recruiting
        • Houston Methodist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 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.
  2. The patient is scheduled for an elective robotic approach with the use of OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR.
  3. 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.
  4. Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria.
  5. 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.
  6. Subject is able to complete Quality of Life (QoL) and pain questionnaires.
  7. Subject is at least 21 years old.
  8. Subject is willing to comply and able to participate fully in, and for the full duration of, the study including follow-up requirements.

Exclusion Criteria at Baseline:

  1. Subject has a BMI of > 40
  2. Subject meets CDC/SSI Wound Classification Class IV (Dirty-Infected) criteria
  3. Subject is female and is pregnant or plans to become pregnant during the course of the study.
  4. Subject has a life expectancy of < 2 years making it unlikely that the subject will successfully achieve two-year follow-up.
  5. Subject has recent history of drug or alcohol abuse (in last 3 years).
  6. Subject has an allergy to ovine-derived products.
  7. Subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial.
  8. Subject has a strangulated hernia.

Exclusion Criteria Intraoperative:

  1. Subject requires implant that cannot be introduced into the surgical site during the procedure via port or an existing incision.
  2. Subject unable to receive OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR at time of surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: OviTex Reinforced Tissue Matrix
This is a single-arm study. All study subjects will receive OviTex.
Device: OviTex Reinforced Tissue Matrix
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
occurring within the first 3 months of the ventral or inguinal hernia repair
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
occurring within the first 3 months of the ventral or inguinal hernia repair.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Late surgical site occurrences or wound related events
Time Frame: occurring > 3 months after index surgery
Incidence of late post-operative surgical site occurrences or wound related events noted at the hernia repair site
occurring > 3 months after index surgery
Late post-operative complications
Time Frame: occurring > 3 months after index surgery.
Incidence of other late post-operative complications
occurring > 3 months after index surgery.
Patient Reported Outcomes
Time Frame: Assessed at day 30, day 90, 12 months, and 24 months post-op
Patient Reported Outcomes (QoL and pain assessments)
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
True hernia recurrence at the site of surgery
at post-operative day 90 and months 12 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tela Bio Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
MCRA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Geoffrey Slayden, MD, St. Lukes Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TB.2020.01.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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