RecruitingNCT07181876

Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System


Sponsor

Distalmotion SA

Enrollment

140 participants

Start Date

Nov 26, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 22 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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

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Interventions

DEVICEinguinal hernia repair

Robotic-assisted inguinal hernia repair with the DEXTER robotic surgery system


Locations(2)

Northtowns Ambulatory Surgical Center (NASC)

Buffalo, New York, United States

Memorial Hermann-Texas Medical Center - UT Health Houston

Houston, Texas, United States

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NCT07181876


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