RecruitingNCT07181876
Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System
Sponsor
Distalmotion SA
Enrollment
140 participants
Start Date
Nov 26, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
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
Min Age: 22 Years
Inclusion Criteria3
- 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
Exclusion Criteria3
- 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
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Interventions
DEVICEinguinal hernia repair
Robotic-assisted inguinal hernia repair with the DEXTER robotic surgery system
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07181876
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