Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System (RAS-ACCESS)

Distalmotion

Status: Enrolling

Conditions: Inguinal Hernia Repair

Treatments: Device: inguinal hernia repair

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT07181876

2025-03

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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