RecruitingNot ApplicableNCT04779918

Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh

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

Sponsor

Tela Bio Inc

Enrollment

160 participants

Start Date

Apr 29, 2021

Study Type

INTERVENTIONAL

Conditions

Hernia, Inguinal Hernia, Ventral

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

Min Age: 21 Years

Inclusion Criteria8

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, or OviTex 1S Permanent.
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.
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 Criteria10

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.
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, or OviTex 1S Permanent time of surgery.

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Interventions

DEVICEOviTex 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.