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Recruiting
NCT07181876
Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System
Conditions: Inguinal Hernia Repair
Sex: All
Ages: 22 Years – N/A
Healthy volunteers: No
Enrollment: 140
Sponsor: Distalmotion SA
Location: Northtowns Ambulatory Surgical Center (NASC) Buffalo New York
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
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
Source: ClinicalTrials.gov (NCT07181876). StuddyBuddy aggregates publicly available trial information.