Inguinal Hernia Repair Clinical Trial
— RAS-AheadOfficial title:
Robotic Minimally Invasive Inguinal Hernia Repair With Dexter
NCT number | NCT05873582 |
Other study ID # | 2023-01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2, 2023 |
Est. completion date | October 23, 2023 |
Verified date | January 2024 |
Source | Distalmotion SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing primary transperitoneal unilateral or bilateral inguinal hernia repair.
Status | Completed |
Enrollment | 50 |
Est. completion date | October 23, 2023 |
Est. primary completion date | October 23, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Aged > 18 years - Patients planned to undergo elective robot-assisted and laparoscopic surgery for primary unilateral or bilateral inguinal hernia repair using one camera port, two ports for the manipulating instruments, and additional ports as needed. - Able to provide Informed Consent according to local regulation Exclusion Criteria: - Morbidly obese patients (BMI > 40) - Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments - Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery - Bleeding diathesis - Pregnancy - Patients with pacemakers or internal defibrillators - Any planned concomitant procedures - Patient deprived of liberty by administrative or judicial decision or under legal guardianship - Participation in another interventional clinical trial |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier de Saintes | Saintes | |
Germany | UKSH Kiel | Kiel | |
Switzerland | Kantonspital Winterthur | Winterthur |
Lead Sponsor | Collaborator |
---|---|
Distalmotion SA | confinis AG |
France, Germany, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety: occurrence of serious (Clavien - Dindo grades III-V), device-related, adverse events | perioperatively up to 30 days | ||
Primary | Performance: successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach | intraoperative |
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