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Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh
RecruitingHealthy volunteers welcome
A Prospective Study Evaluating the Clinical Outcomes of Ventral or Inguinal Hernias Treated Robotically With OviTex® Reinforced Tissue Matrix
Who can join
Ages 21 and older · All sexes · Healthy volunteers welcome
Full 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.
About the study
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.
What is being tested
- OviTex Reinforced Tissue Matrix (device)
Sponsor: Tela Bio Inc · Participants: 160 · Started: Apr 29, 2021
Contact the study team
- Melissa LaMantia · Phone: 757-761-4922
- Danielle Campbell · Phone: 717-676-2589
Official record on ClinicalTrials.gov — NCT04779918
Locations in the U.S.
| Alabama | University of South Alabama, Mobile |
| Kentucky | University of Louisville, Louisville |
| Michigan | Munson Healthcare, Traverse City |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.