RECRUITING

Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh

Description

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.

Conditions

Hernia, VentralHernia, Inguinal
Talk to us

Related Conditions:

Hernia, VentralHernia, Inguinal

Study Overview

On this page

Study Details

Study overview

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.

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

Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh

Condition
Hernia, Ventral
Intervention / Treatment

-

Contacts and Locations

Denver

SurgOne, Denver, Colorado, United States, 802210

Destin

GenesisCare, Destin, Florida, United States, 325541

Fort Myers

Surgical Healing Arts Center, Fort Myers, Florida, United States, 33912

Overland Park

St. Luke's Hospital, Overland Park, Kansas, United States, 66213

Louisville

University of Louisville Surgical Oncology, Louisville, Kentucky, United States, 40202

Traverse City

Munson Healthcare, Traverse City, Michigan, United States, 49684

Roslyn

St. Francis Hospital, Roslyn, New York, United States, 11576

Houston

Houston Methodist, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.
  • 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.

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Tela Bio Inc,

Geoffrey Slayden, MD, PRINCIPAL_INVESTIGATOR, St. Lukes Hospital

Study Record Dates

2027-12-30