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

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: Recruiting
• Conditions: Hernia, Inguinal; Hernia, Ventral
• Intervention / Treatment: Device: OviTex Reinforced Tissue Matrix

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: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danielle Campbell; Phone Number: 717-676-2589; Email: dcampbell@telabio.com
• Study Contact Backup: Name: Melissa LaMantia; Phone Number: 757-761-4922; Email: mlamantia@telabio.com

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36617
      • Recruiting
      • University of South Alabama
      • Principal Investigator: Daniel McMahon, MD
      • Contact: Valrie Patterson, RN; Phone Number: 251-445-9626; Email: valriepatterson@health.southalabama.edu
  • 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: Dajana Nenadovic, RN; Phone Number: 502-588-4571; Email: dajana.nenadovic@uoflhealth.org
  • Michigan
    • Traverse City, Michigan, United States, 49684
      • Recruiting
      • Munson Healthcare
      • Contact: Kelly VanSchouwen; Email: kelly@researchtex.com
      • 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      • Withdrawn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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	occurring within the first 3 months of the ventral or inguinal hernia repair
Early post-operative complications	Incidence of other early post-operative complications	occurring within the first 3 months of the ventral or inguinal hernia repair.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	occurring > 3 months after index surgery
Late post-operative complications	Incidence of other late post-operative complications	occurring > 3 months after index surgery.
Patient Reported Outcomes	Patient Reported Outcomes (QoL and pain assessments)	Assessed at day 30, day 90, 12 months, and 24 months post-op
Hernia Recurrence	True hernia recurrence at the site of surgery	at post-operative day 90 and months 12 and 24

Collaborators and Investigators

• Sponsor: Tela Bio Inc
• Collaborators: MCRA
• Investigators: Principal Investigator: Geoffrey Slayden, MD, St. Lukes Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: use of mesh; robotic hernia repair
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Hernia, Inguinal; Hernia, Ventral
• Other Study ID 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