inguinal hernia repair: Robotic-assisted inguinal hernia repair with the DEXTER robotic surgery system
Study 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
Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Primary safety outcome — up to 30 days after surgery Occurrence of Clavien-Dindo grades III-V adverse events
Primary efficacy outcome — Intraoperative Successful completion of the DEXTER-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach
Trial sites (2)
Facility
City
Region
Status
Northtowns Ambulatory Surgical Center (NASC)
Buffalo
New York
Recruiting
Memorial Hermann-Texas Medical Center - UT Health Houston
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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