Robotically repairing ventral or inguinal hernias using OviTex mesh

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

This study is testing whether using a special mesh called OviTex in robotic surgery can help people with ventral or inguinal hernias recover better and avoid complications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Tela Bio Inc (Industry-sponsored)
• Locations: 10 sites (Mobile, Alabama and 9 other locations)
• Trial ID: NCT04779918 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 and older with ventral or inguinal hernias requiring surgical repair using an implant.

Not a fit: Patients with hernias that do not require surgical repair or those with contraindications for robotic surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced recurrence rates for patients undergoing hernia repair.

How similar studies have performed: Other studies have shown promising results with robotic hernia repairs, but the specific use of OviTex mesh in this context is relatively novel.

Eligibility criteria

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 this trial is running

Mobile, Alabama and 9 other locations

• University of South Alabama — Mobile, Alabama, 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)
• St. Luke's Hospital — Overland Park, Kansas, United States (Active_not_recruiting)
• University of Louisville — Louisville, Kentucky, United States (Recruiting)
• Munson Healthcare — Traverse City, Michigan, United States (Recruiting)
• St. Francis Hospital — Roslyn, New York, United States (Withdrawn)
• Mohawk Valley Health System — Utica, New York, United States (Withdrawn)
• Houston Methodist — Houston, Texas, United States (Active_not_recruiting)

Study contacts

• Principal investigator: Geoffrey Slayden, MD — St. Lukes Hospital
• Study coordinator: Melissa LaMantia

Conditions Hernia, Ventral; Hernia, Inguinal; use of mesh; robotic hernia repair