Robotically repairing ventral or inguinal hernias using OviTex mesh

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the post-operative complications and recurrence rates of ventral or inguinal hernias treated with OviTex mesh using a robotic surgical approach. Up to 160 participants will be enrolled across 20 sites, all receiving the OviTex Reinforced Tissue Matrix for their hernia repair. The study aims to gather data on the effectiveness and safety of this specific mesh in robotic surgeries.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of South Alabama
  Mobile, Alabama, United States Recruiting
• University of Louisville
  Louisville, Kentucky, United States Recruiting
• Munson Healthcare
  Traverse City, Michigan, United States Recruiting
• SurgOne
  Denver, Colorado, United States Active not recruiting
• GenesisCare
  Destin, Florida, United States Terminated
• Surgical Healing Arts Center
  Fort Myers, Florida, United States Terminated

Study contacts

• Principal investigator: Geoffrey Slayden, MD — St. Lukes Hospital
• Study coordinator: Melissa LaMantia
• Email: mlamantia@telabio.com
• Phone: 757-761-4922

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.