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NCT Number: NCT04779918

Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh

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.

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Key information

Conditions

HERNIA, VENTRAL Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Alabama, Mobile, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

at Baseline:

  • 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.
  • 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.

Exclusion criteria

Intraoperative:

  • 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.

Treatment and study plan

OviTex Reinforced Tissue Matrix

Device

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. Late post-operative complications

    Time frame: occurring > 3 months after index surgery.

    Incidence of other late post-operative complications

  3. 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)

  4. Hernia Recurrence

    Time frame: at post-operative day 90 and months 12 and 24

    True hernia recurrence at the site of surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Campbell

CONTACT

[email protected]

717-676-2589

Melissa LaMantia

CONTACT

[email protected]

757-761-4922

Sponsors and collaborators

Lead sponsor

Tela Bio Inc

Industry

Collaborators

  • MCRA

Registry information

Official study title

A Prospective Study Evaluating the Clinical Outcomes of Ventral or Inguinal Hernias Treated Robotically With OviTex® Reinforced Tissue Matrix

Acronym: BRAVOII

Important dates

Study start
2021
Primary completion
2027
Study completion
2029
First posted
Mar 3, 2021
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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