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

NCT ID: NCT05208138

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-20
• Study Completion Date: 2022-06-15

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

Bariatric operation with the Senhance surgical system

Group Type: EXPERIMENTAL

Senhance Surgical System from Asensus

Intervention Type: DEVICE

Bariatric operation with the Senhance Surgical System

Interventions

Senhance Surgical System from Asensus

Bariatric operation with the Senhance Surgical System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Informed Consent as documented by signature (Appendix Informed Consent Form)
• ≥ 18 years old
• Capable of judgment
• Patient eligible for laparoscopic bariatric surgery according to the SMOB (Swiss Study Group for Morbid Obesity) -Criteria and having a bariatric operation (including Sleeve gastrectomy, Y-Roux gastric bypass, Omega-loop gastric bypass) using SenhanceTM Surgical System

Exclusion Criteria

• < 18 years of age
• Participants incapable of judgment or participants under tutelage
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• No informed consent signed
• Women who are pregnant
• High risk patients (immunosuppression, myopathy, liver cirrhosis, severe heart or lung disease, renal failure)
• Contra-indication for laparoscopic surgery
• Prior upper gastro intestinal tract operations (such as hepatobiliary, pancreatic, gastrooesophageal, anti-reflux, bariatric surgery or splenectomy except cholecystectomy) or open surgery with incision above the umbilicus

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philipp C Nett, MD

Role: STUDY_DIRECTOR

Inselspital Universitätsspital Bern

Locations

Inselspital Universitätsspital Bern

Bern, , Switzerland

Countries

Switzerland

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

STD0005853

Identifier Type: -

Identifier Source: org_study_id