Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorDistalmotion SA

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

No treatment groups listed

Sponsors and collaborators

Distalmotion SA

Lead sponsor

Veranex, Inc.

Collaborator