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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date January 2024
Source Distalmotion SA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Robotic-assisted inguinal hernia repair
Primary transperitoneal unilateral or bilateral inguinal hernia repair with the Dexter robotic system

Locations

Country Name City State
France Centre Hospitalier de Saintes Saintes
Germany UKSH Kiel Kiel
Switzerland Kantonspital Winterthur Winterthur

Sponsors (2)

Lead Sponsor Collaborator
Distalmotion SA confinis AG

Countries where clinical trial is conducted

France,  Germany,  Switzerland, 

Outcome

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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