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

NCT07181876 | Recruiting

• 1 other identifier: 2025-03
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Primary safety outcome

  Occurrence of Clavien-Dindo grades III-V adverse events

  up to 30 days after surgery

• Primary efficacy outcome

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

  Intraoperative

Interventions

inguinal hernia repair DEVICE

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

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing unilateral or bilateral inguinal hernia repair

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Distalmotion SA: lead
• Veranex, Inc.: collaborator

Study Sites (2)

Northtowns Ambulatory Surgical Center (NASC)

Buffalo, New York, 14221, United States

NOT YET RECRUITING

Memorial Hermann-Texas Medical Center - UT Health Houston

Houston, Texas, 77030, United States

RECRUITING

Central Study Contacts

Pascal Lehmann

CONTACT

+41215105890; pascal.lehmann@distalmotion.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: November 26, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (2)