Inguinal Hernia Repair
Conditions
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, including a variety of representative disease etiologies and demographic groups.
Interventions
DEVICEinguinal hernia repair
Robotic-assisted inguinal hernia repair with the DEXTER robotic surgery system
Sponsors
Distalmotion SA
Veranex, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTPascal Lehmann
Outcome results
None listed