Recruiting

Observational Study

Sponsor:

Distalmotion SA

Code:

NCT07181876

Conditions

Inguinal Hernia Repair

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

inguinal hernia repair

Study Details

Brief 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.

Conditions

Inguinal Hernia Repair

Study ID

NCT07181876

Start date

Nov 26, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Enrollment

140 participants

Anticipated

Interventions and Outcome Measures

Interventions

inguinal hernia repair

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

Primary outcome measure

  • Primary safety outcome [ Time Frame: up to 30 days after surgery ]
  • Primary efficacy outcome [ Time Frame: Intraoperative ]

Central Contacts and Locations

Central contacts

Pascal Lehmann

+41215105890pascal.lehmann@distalmotion.com

Locations

Northtowns Ambulatory Surgical Center (NASC)

Recruiting

Buffalo, New York, United States, 14221

Memorial Hermann-Texas Medical Center - UT Health Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Jonah Stulberg, MD

+1 (713) 486-1330jonha.j.stulberg@uth.tmc.edu

More Information

Sponsor

Distalmotion SA

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Distalmotion SA on 2026-07-06.