NCT07181876Recruiting
Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System
Distalmotion SA
Start Date
11/26/2025
Completion Date
12/1/2029
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 Criteria
Age Range: 22 years to No maximum
Inclusion Criteria:
* 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 Criteria:
* 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
Interventions
DEVICE
inguinal hernia repair
Conditions
Inguinal Hernia Repair
Locations
Northtowns Ambulatory Surgical Center (NASC)
Buffalo, New York 14221
United States
Memorial Hermann-Texas Medical Center - UT Health Houston
Houston, Texas 77030
United States