Clinical Trials in the USA / NCT07181876
Recruiting
Observational
Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System
NCT07181876 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Inguinal Hernia Repair
Investigational drug(s) / intervention(s)
inguinal hernia repair
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
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 | Houston | Texas | Recruiting |
More Distalmotion SA trials in the USA
Official registry record
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.
View NCT07181876 on ClinicalTrials.gov ↗ ← All trials in the USA