Status:
RECRUITING
Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh
Lead Sponsor:
Tela Bio Inc
Collaborating Sponsors:
MCRA
Conditions:
Hernia, Ventral
Hernia, Inguinal
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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 ...
Detailed Description
This study is intended to evaluate the post-operative complications and recurrence following the use of OviTex in ventral or inguinal hernias being treated robotically. It is a single-arm study and al...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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 Criteria at Baseline:
- 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.
- Exclusion Criteria Intraoperative:
- 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.
Exclusion
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04779918
Start Date
April 29 2021
End Date
December 30 2027
Last Update
October 10 2025
Active Locations (10)
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1
University of South Alabama
Mobile, Alabama, United States, 36617
2
SurgOne
Denver, Colorado, United States, 802210
3
GenesisCare
Destin, Florida, United States, 325541
4
Surgical Healing Arts Center
Fort Myers, Florida, United States, 33912