Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorTela Bio Inc
About this trial
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.
Eligibility criteria
Qualifiers
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, OviTex 1S Permanent, or OviTex IHR.
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.
Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- OviTex Reinforced Tissue Matrix
Treatment groups
160 Participants
are divided into 1 treatment groupSponsors and collaborators
Tela Bio Inc
Lead sponsor
MCRA
Collaborator
Source ClinicalTrials.gov