Status:
NOT_YET_RECRUITING
Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System
Lead Sponsor:
Distalmotion SA
Collaborating Sponsors:
Veranex, Inc.
Conditions:
Inguinal Hernia Repair
Eligibility:
All Genders
22+ years
Brief 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, inclu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT07181876
Start Date
October 1 2025
End Date
December 1 2029
Last Update
September 18 2025
Active Locations (2)
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1
Northtowns Ambulatory Surgical Center (NASC)
Buffalo, New York, United States, 14221
2
Memorial Hermann-Texas Medical Center - UT Health Houston
Houston, Texas, United States, 77030