About this trial
The purpose of this post-market, observational study is to collect data under anticipated conditions of use that demonstrates that DEXTER performs as intended in the intended patient population, including a variety of representative disease etiologies and demographic groups.
Eligibility criteria
Qualifiers
Subject is ≥ 22 years of age at time of enrollment/consent
Subject is indicated for and planned to undergo robot-assisted and laparoscopic surgery for unilateral or bilateral inguinal hernia repair
Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form
Disqualifiers
Subject with any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments and/or general non-procedure specific contraindications to endoscopic surgery including bleeding diathesis and pregnancy
Subject is participating in another clinical investigation at the time of enrollment or planned participation at any time during this clinical study
Subject has a known or suspected medical condition that, in the opinion of the Investigator, may put the subject at risk for participation in this clinical study
Trial design
Treatments tested in this trial
- inguinal hernia repair
Treatment groups
Sponsors and collaborators
Distalmotion SA
Lead sponsor
Veranex, Inc.
Collaborator