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.
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
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
Adult patients undergoing unilateral or bilateral inguinal hernia repair
Case-only
Prospective
inguinal hernia repair
DeviceRobotic-assisted inguinal hernia repair with the DEXTER robotic surgery system
Primary safety outcome
Occurrence of Clavien-Dindo grades III-V adverse events
Primary efficacy outcome
Successful completion of the DEXTER-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach
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Distalmotion SA
Lead sponsor
Veranex, Inc.
Collaborator
