Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System
Purpose
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.
Condition
- Inguinal Hernia Repair
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Recruiting Locations
Memorial Hermann-Texas Medical Center - UT Health Houston
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
More Details
- Status
- Recruiting
- Sponsor
- Distalmotion SA