Robotic minimally invasive repair of inguinal hernias with the DEXTER system
Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System
Distalmotion SA · NCT07181876
The DEXTER robotic system will be tested in adults having robot-assisted or laparoscopic inguinal hernia repair to see if it performs well across different patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Distalmotion SA (industry) |
| Locations | 2 sites (Buffalo, New York and 1 other locations) |
| Trial ID | NCT07181876 on ClinicalTrials.gov |
What this trial studies
This is a post‑market, observational study collecting real‑world data on use of the DEXTER robotic system for unilateral or bilateral inguinal hernia repair. Patients aged 22 and older who are planned for robot‑assisted or laparoscopic repair will be enrolled and followed under normal clinical conditions. The study captures a variety of disease causes and demographic groups to show device performance across representative patients. Standard surgical and follow‑up measures will be recorded but no experimental treatment assignments are made.
Who should consider this trial
Good fit: Adults aged 22 or older who are indicated for and scheduled to undergo robot‑assisted or laparoscopic unilateral or bilateral inguinal hernia repair and can give informed consent are eligible.
Not a fit: Patients with contraindications to endoscopic surgery (for example bleeding diathesis or pregnancy), those in other clinical investigations, or those judged by the investigator to be at increased risk are not likely to benefit from participation.
Why it matters
Potential benefit: If successful, this could support wider use of the DEXTER system and may help maintain consistent minimally invasive repairs that could reduce pain and speed recovery for some patients.
How similar studies have performed: Robotic and laparoscopic approaches to inguinal hernia repair have shown comparable outcomes in prior research, but device‑specific post‑market data for DEXTER are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Buffalo, New York and 1 other locations
- Northtowns Ambulatory Surgical Center (NASC) — Buffalo, New York, United States (NOT_YET_RECRUITING)
- Memorial Hermann-Texas Medical Center - UT Health Houston — Houston, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Pascal Lehmann
- Email: pascal.lehmann@distalmotion.com
- Phone: +41215105890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inguinal Hernia Repair