NCT05208138

Feasibility and Safety of Robotic Bariatric Surgery Using the SenhanceTM Surgical System

Feasibility and Safety of Robotic Bariatric Surgery Using the SenhanceTM Surgical System: a Pilot Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluating feasibility and safety of the Senhance Surgical System with digital laparoscopy in bariatric surgery.

Detailed description

The introduction of laparoscopy in bariatric surgery is considered a milestone to improve postoperative outcomes in terms of less complications and shorter hospital stay. Furthermore, conversion into open surgery is associated with higher postoperative morbidity and mortality in bariatric surgery. Nevertheless, the laparoscopic technique has several drawbacks as lack of tactile feedback, limited degrees of freedom of the laparoscopic instruments, bad depth perception and limited field of view and therefore a flat learning curve. Senhance Surgical System from Asensus Surgical is an innovative robotic technique which presents haptic feedback, an eyetracker system, microinvasive surgery (with 3mm instruments), reusable instruments and a lower docking time when compared to usual robotic systems. The use of this new technology has not been systematically analysed in bariatric surgery. Nevertheless, its use is expected to be safe and efficient and may also present some advantages over conventional laparoscopic surgery. The primary endpoint of the study is the safety of this new robotic platform in bariatric surgery (intraoperative complications, postoperative morbidity, and postoperative mortality). Secondary outcome is the feasibility of this new technology in bariatric surgery (docking time, operation time, conversion rate, length of hospital stay, and rehospitalisation rate).

Conditions

• Bariatric Surgery Candidate

Interventions

Type	Name	Description
DEVICE	Senhance Surgical System from Asensus	Bariatric operation with the Senhance Surgical System

Timeline

• Start date: 2022-01-20
• Primary completion: 2022-06-15
• Completion: 2022-06-15
• First posted: 2022-01-26
• Last updated: 2022-11-04

Locations

1 site across 1 country: Switzerland