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NCT04779918NARecruitingAccepts Healthy Volunteers

Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh

Tela Bio Inc

Start Date

4/29/2021

Completion Date

12/30/2029

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.

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.

Eligibility Criteria

Age Range: 21 years to No maximum

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.

Interventions

DEVICE

OviTex Reinforced Tissue Matrix

Interested in This Trial?

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Conditions

Hernia, VentralHernia, Inguinal

Locations

University of South Alabama

Mobile, Alabama 36617

United States

SurgOne

Denver, Colorado 802210

United States

GenesisCare

Destin, Florida 325541

United States

Surgical Healing Arts Center

Fort Myers, Florida 33912

United States

St. Luke's Hospital

Overland Park, Kansas 66213

United States

University of Louisville

Louisville, Kentucky 40202

United States

Munson Healthcare

Traverse City, Michigan 49684

United States

St. Francis Hospital

Roslyn, New York 11576

United States

Mohawk Valley Health System

Utica, New York 13502

United States

Houston Methodist

Houston, Texas 77030

United States