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

NCT07884994 | Recruiting

• 2 other identifiers: 2026-101703-BO-ffDRKS00040512
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity (BMI > 35); Obesity (BMI > 35) and Diabetes Mellitus; Obesity (BMI > 35) and Dyslipemia; Obesity (BMI > 35) and High Blood Pressure

Keywords

Robotic Surgery; HUGO RAS; Metabolic and Bariatric Surgery; Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

• Proportion of robotic sleeve gastrectomy procedures successfully completed using the Hugo™ Robotic-Assisted Surgery (RAS) system including LigaSure™ RAS without intraoperative conversion to conventional laparoscopy or open surgery.

  From beginning to the end of the Procedure

Secondary Outcomes (12)

• Port Placement Time

  During surgery

• Docking Time

  During surgery

• Console Time

  During surgery

• Total Operative Time

  During surgery

• Intraoperative Complications

  During surgery

Study Arms (1)

Sleeve Gastrectomy using Hugo RAS platform

EXPERIMENTAL

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.

Device: Sleeve Gastrectomy using Hugo RAS platform

Interventions

Sleeve Gastrectomy using Hugo RAS platform DEVICE

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.

Sleeve Gastrectomy using Hugo RAS platform

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Body mass index (BMI) ≥ 40 kg/m², or BMI ≥ 35 kg/m² in the presence of at least one obesity-related comorbidity
• Scheduled for elective primary sleeve gastrectomy
• Ability to provide written informed consent
• Sufficient language proficiency to participate in the study.

You may not qualify if:

• Previous upper abdominal surgery
• Revisional bariatric surgery
• American Society of Anesthesiologists (ASA) physical status classification ≥ IV
• Oral anticoagulation therapy
• Presence of a ventriculoperitoneal shunt
• Severe hepatomegaly or other contraindications to a robotic surgical approach

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Medtronic: collaborator

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

RECRUITING

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Oliver Mann, Prof Dr

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Plitzko, Dr

CONTACT

+4915222842144; g.plitzko@uke.de

Notz Sara, Dr

CONTACT

+4915222816807; s.notz@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2026
• First Posted: October 21, 2026
• Study Start: June 4, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-07

Locations

DE (1)