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Recruiting

NCT Number: NCT07181876

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

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.

Recruiting

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Key information

Conditions

Inguinal Hernia Repair

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northtowns Ambulatory Surgical Center (NASC), Buffalo, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inguinal hernia repair

Device

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

Primary outcomes

  1. Primary safety outcome

    Time frame: up to 30 days after surgery

    Occurrence of Clavien-Dindo grades III-V adverse events

  2. Primary efficacy outcome

    Time frame: Intraoperative

    Successful completion of the DEXTER-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach

Study contacts

Contact information is provided by the study sponsor or research team.

Pascal Lehmann

CONTACT

[email protected]

+41215105890

Sponsors and collaborators

Lead sponsor

Distalmotion SA

Industry

Collaborators

  • Veranex, Inc.

Registry information

Acronym: RAS-ACCESS

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Sep 18, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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