Robotic Minimally Invasive Inguinal Hernia Repair With Dexter

Inguinal Hernia Repair Clinical Trial

— RAS-Ahead  

Official title:

Robotic Minimally Invasive Inguinal Hernia Repair With Dexter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05873582
• Other study ID #: 2023-01
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia Repair

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