Robot-assisted sleeve gastrectomy with Hugo system feasibility
Official title: HUGO-SLEEVE: Evaluating the Feasibility of Robotic Sleeve Gastrectomy With a New Platform
Run by Universitätsklinikum Hamburg-Eppendorf · NCT07884994 · Data updated 2026-11-12
This study tests whether sleeve gastrectomy can be safely done using the Hugo robotic system in adults with severe obesity.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg, Free and Hanseatic City of Hamburg) |
| Status | Recruiting |
| Started | June 4, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT07884994 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with BMI ≥40 or BMI ≥35 with at least one obesity-related comorbidity, planned for elective primary sleeve gastrectomy, and eligible for robotic surgery.
✕Probably not a fit
Patients with contraindications to robotic surgery or requiring revision procedures may not benefit and could face higher risk or no improvement.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The HUGO-SLEEVE trial is a prospective, single-center, single-arm study assessing the feasibility and safety of performing primary sleeve gastrectomy with the Hugo robotic-assisted system. It collects intraoperative data such as port placement, docking, and console times, as well as postoperative outcomes including complications and length of stay. Fifty adults with BMI ≥40 or BMI ≥35 with obesity-related comorbidities are enrolled and followed through postoperative day 180. The study also uses the LigaSure RAS device to evaluate its role in this robotic approach. Primary endpoint is the proportion of procedures completed without conversion to another technique or approach.
Why it matters
Potential benefit: If successful, the approach could offer a safe, reliable robotic option for sleeve gastrectomy, potentially improving precision and recovery.
How similar studies have gone: Previous robotic sleeve procedures have shown feasibility in other systems; this study flags Hugo RAS-specific feasibility, with limited prior experience.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where it's running
-
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany Recruiting
Study contacts
- Principal investigator: Oliver Mann, Prof Dr — Universitätsklinikum Hamburg-Eppendorf
- Study coordinator: Gabriel Plitzko, Dr
- Email: g.plitzko@uke.de
- Phone: +4915222842144
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.