NCT07884994 HUGO-SLEEVE: Evaluating the Feasibility of Robotic Sleeve Gastrectomy With a New Platform
| NCT ID | NCT07884994 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf |
| Condition | Obesity (BMI > 35) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-06-04 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-06-04 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Oliver Mann, Prof Dr
PRINCIPAL INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Frequently Asked Questions
Who can join the NCT07884994 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obesity (BMI > 35). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07884994 currently recruiting?
Yes, NCT07884994 is actively recruiting participants. Contact the research team at g.plitzko@uke.de for enrollment information.
Where is the NCT07884994 trial being conducted?
This trial is being conducted at Hamburg, Germany.
Who is sponsoring the NCT07884994 clinical trial?
NCT07884994 is sponsored by Universitätsklinikum Hamburg-Eppendorf. The principal investigator is Oliver Mann, Prof Dr at Universitätsklinikum Hamburg-Eppendorf. The trial plans to enroll 50 participants.
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