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RECRUITING
NCT07884994
NA

HUGO-SLEEVE: Evaluating the Feasibility of Robotic Sleeve Gastrectomy With a New Platform

Sponsor: Universitätsklinikum Hamburg-Eppendorf

View on ClinicalTrials.gov

Summary

Severe obesity is a chronic condition that can lead to a range of serious health problems. One common treatment option is sleeve gastrectomy, a weight-loss operation in which the size of the stomach is reduced. These procedures are increasingly being performed with the support of robotic surgical systems. However, there is still limited clinical experience with the Hugo™ Robotic-Assisted Surgery System for this type of operation. The aim of this study is to evaluate whether sleeve gastrectomy can be performed safely and reliably using the Hugo™ system. In particular, the study will assess whether the operation can be completed as planned with the robotic system and will examine outcomes during and after surgery. The study will include 50 adults with severe obesity who are scheduled to undergo sleeve gastrectomy. Information will be collected during the operation, including the duration of different surgical steps and the occurrence of any complications. Participants will be followed for six months after surgery. During this period, information on pain, complications, hospital stays, readmissions, and quality of life will be collected. The study aims to provide important information about the safe introduction and use of the Hugo™ system for this established weight-loss procedure.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-06-04

Completion Date

2027-12-31

Last Updated

2026-10-21

Healthy Volunteers

No

Interventions

DEVICE

Sleeve Gastrectomy using Hugo RAS platform

Elective primary sleeve gastrectomy performed using the Hugo™ Robotic-Assisted Surgery (RAS) system, including the LigaSure™ RAS vessel-sealing system, in patients with obesity and a body mass index (BMI) ≥ 40 kg/m² or a BMI ≥ 35 kg/m² in combination with at least one obesity-related comorbidity.

Locations (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, Germany