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RecruitingNCT07181876RAS-ACCESSUpdated Jul 6, 2026

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

An observational study in Inguinal Hernia Repair, sponsored by Distalmotion SA. Recruiting at 2 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by Distalmotion SA · Observational

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
140
Ages
22 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Inguinal Hernia Repair
03

In context

Lead sponsor

Distalmotion SA is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients undergoing unilateral or bilateral inguinal hernia repair

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
140 participants (estimated)
Patient registry
No

Interventions

  • Deviceinguinal hernia repair

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

06

What researchers measure

Primary outcomes

  1. Primary safety outcome

    Occurrence of Clavien-Dindo grades III-V adverse events

    Time frame: up to 30 days after surgery

  2. Primary efficacy outcome

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

    Time frame: Intraoperative

07

Study locations

2 of 2 sites recruiting
  • Northtowns Ambulatory Surgical Center (NASC)
    Buffalo, New York 14221, United States
    Recruiting
  • Memorial Hermann-Texas Medical Center - UT Health Houston
    Houston, Texas 77030, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07181876
Lead sponsor
Distalmotion SA
Collaborators
Veranex, Inc.
Responsible party
Sponsor
First posted
Sep 18, 2025
Start date
Nov 26, 2025
Primary completion
Dec 2028 (estimated)
Completion
Dec 2029 (estimated)
Last update
Jul 6, 2026

Study contacts

Pascal Lehmann
Contact
pascal.lehmann@distalmotion.com
+41215105890

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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