Actively Recruiting
Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System
Led by Distalmotion SA · Updated on 2026-01-22
140
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
D
Distalmotion SA
Lead Sponsor
V
Veranex, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This observational study evaluates the use of the DEXTER robotic surgery system for minimally invasive inguinal hernia repair. It aims to collect data on how well the device performs in real-world conditions among a diverse group of patients with various types of inguinal hernias. The study is sponsored by Distalmotion SA and focuses on safety and effectiveness of the robotic-assisted procedure. Participants will undergo robot-assisted or laparoscopic surgery for unilateral or bilateral inguinal hernia repair using the DEXTER system. The study observes the procedure and follows patients up to 30 days after surgery to assess primary safety and efficacy outcomes. No experimental treatments or randomization are involved since it is a post-market observational study. During the study, participants will be monitored for safety and surgical outcomes through assessments conducted during and after the operation. The main measures include intraoperative effectiveness and any safety issues within 30 days post-surgery. Participants are expected to comply with study procedures and provide informed consent. The study starts in November 2025 and will continue until December 2029.
CONDITIONS
Brief Title
Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is 22 years of age or older at the time of enrollment/consent
- Subject is planned to undergo robot-assisted or laparoscopic surgery for unilateral or bilateral inguinal hernia repair
- Subject is able and willing to comply with the protocol requirements and has signed the informed consent form
You will not qualify if you...
- Subject has contraindications for conventional endoscopes, endoscopic surgical instruments, or general contraindications to endoscopic surgery such as bleeding disorders or pregnancy
- Subject is participating in another clinical investigation at enrollment or during the study
- Subject has a known or suspected medical condition that may increase risk for participation as judged by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants undergo robotic-assisted inguinal hernia repair using the DEXTER robotic surgery system and receive immediate post-operative care.
Approximately 6 post-operative visits
Trial Site Locations
Total: 2 locations
1
Northtowns Ambulatory Surgical Center (NASC)
Buffalo, New York, United States, 14221
Not Yet Recruiting
2
Memorial Hermann-Texas Medical Center - UT Health Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
P
Pascal Lehmann
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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