Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh

Last updated: January 8, 2025
Sponsor: Tela Bio Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Treatment

OviTex Reinforced Tissue Matrix

Clinical Study ID

NCT04779918
TB.2020.01.01
  • Ages > 21
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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, or OviTex 1S Permanent.

  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.

  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, or OviTex 1S Permanent time of surgery.

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: OviTex Reinforced Tissue Matrix
Phase:
Study Start date:
April 29, 2021
Estimated Completion Date:
December 30, 2027

Study 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.

Connect with a study center

  • SurgOne

    Denver, Colorado 802210
    United States

    Active - Recruiting

  • GenesisCare

    Destin, Florida 325541
    United States

    Terminated

  • Surgical Healing Arts Center

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • St. Luke's Hospital

    Overland Park, Kansas 66213
    United States

    Active - Recruiting

  • University of Louisville Surgical Oncology

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Munson Healthcare

    Traverse City, Michigan 49684
    United States

    Active - Recruiting

  • St. Francis Hospital

    Roslyn, New York 11576
    United States

    Site Not Available

  • Houston Methodist

    Houston, Texas 77030
    United States

    Site Not Available

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