Obesity (BMI > 35)NCT07884994
HUGO-SLEEVE: Evaluating the Feasibility of Robotic Sleeve Gastrectomy With a New Platform
A study testing Sleeve Gastrectomy using Hugo RAS platform in people with Obesity (BMI > 35) and Obesity (BMI > 35) and Diabetes Mellitus, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity (BMI > 35), Obesity (BMI > 35) and Diabetes Mellitus, Obesity (BMI > 35) and Dyslipemia
- What is being tested?
- Sleeve Gastrectomy using Hugo RAS platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 4 Jun 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
Gabriel Plitzko, Dr, +4915222842144, g.plitzko@uke.de
Sara Notz, Dr, +4915222816807, s.notz@uke.de
About this study
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.
Read the detailed description
The HUGO-SLEEVE Trial is a prospective, single-center, single-arm interventional study designed to evaluate the feasibility and safety of robotic sleeve gastrectomy using the Hugo™ Robotic-Assisted Surgery System, including the LigaSure™ RAS vessel sealing device, during the early phase of clinical implementation. The study investigates whether the procedure can be performed safely and reliably.
The primary endpoint is the proportion of procedures completed without conversion. Secondary endpoints include intraoperative parameters (port placement time, docking time, console time, total operative time, and intraoperative complications) as well as postoperative outcomes (complications, length of hospital stay, readmissions, reoperations, postoperative pain, time to oral intake and mobilization, and changes in SF-Bari Score).
A total of 50 consecutive patients with a body mass index (BMI) ≥ 40 kg/m² or a BMI ≥ 35 kg/m² in the presence of at least one obesity-related comorbidity who are scheduled to undergo elective primary sleeve gastrectomy will be enrolled. Postoperative follow-up assessments will be performed on postoperative days 1, 2, 3, 30, 90, and 180.
- Conditions
- Obesity (BMI > 35), Obesity (BMI > 35) and Diabetes Mellitus, Obesity (BMI > 35) and Dyslipemia, Obesity (BMI > 35) and High Blood Pressure
- Being tested
- Sleeve Gastrectomy using Hugo RAS platform
- Keywords
- Robotic Surgery, HUGO RAS, Metabolic and Bariatric Surgery, Sleeve Gastrectomy
- Medical subject headings
- Obesity, Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve Gastrectomy using Hugo RAS platformDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Sleeve Gastrectomy using Hugo RAS platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From beginning to the end of the Procedure
Secondary outcomes (12)
Port Placement Time
Time interval from skin incision to initiation of robotic system setup and docking
Measured: During surgery
Docking Time
Time interval from completion of port placement to console readiness
Measured: During surgery
Console Time
Duration of active use of the Hugo™ robotic surgical console
Measured: During surgery
Total Operative Time
Time interval from skin incision to skin closure (skin-to-skin time)
Measured: During surgery
Intraoperative Complications
Occurrence of intraoperative complications, such as bleeding or stapling-related issues
Measured: During surgery
Postoperative Complication Rate
Occurrence of postoperative complications
Measured: Within 30 days after surgery
Length of Hospital Stay
Duration of postoperative hospital stay
Measured: Assessed up to postoperative day 30
Readmission Rate
Hospital readmission after sleeve gastrectomy
Measured: Within 6 months after surgery
Reoperation Rate
Requirement for reoperation following sleeve gastrectomy
Measured: Within 6 months after surgery
Postoperative Pain
Patient-reported postoperative pain intensity
Measured: Postoperative day 1, postoperative day 2, and postoperative day 3
Time to Oral Intake and Mobilization
Time to first oral intake and independent mobilization after surgery
Measured: Postoperative day 1, postoperative day 2, and postoperative day 3
Health-Related Quality of Life
Change in health-related quality of life following bariatric surgery
Measured: 3 months and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start4 Jun 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (BMI > 35)Studies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Oliver Mann, Prof Dr, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884994
- Sponsor's protocol ID
- 2026-101703-BO-ff
- Other IDs
- DRKS00040512
- Status last verified
- Jul 2026
- First submitted
- 13 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HUGO-SLEEVE: Evaluating the Feasibility of Robotic Sleeve Gastrectomy With a New Platform
- ClinicalTrials.gov ID
- NCT07884994
- Acronym / sponsor ID
- 2026-101703-BO-ff
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The HUGO-SLEEVE Trial is a prospective, single-center, single-arm interventional study designed to evaluate the feasibility and safety of robotic sleeve gastrectomy using the Hugo™ Robotic-Assisted Surgery System, including the LigaSure™ RAS vessel sealing device, during the early phase of clinical implementation. The study investigates whether the procedure can be performed safely and reliably.
The primary endpoint is the proportion of procedures completed without conversion. Secondary endpoints include intraoperative parameters (port placement time, docking time, console time, total operative time, and intraoperative complications) as well as postoperative outcomes (complications, length of hospital stay, readmissions, reoperations, postoperative pain, time to oral intake and mobilization, and changes in SF-Bari Score).
A total of 50 consecutive patients with a body mass index (BMI) ≥ 40 kg/m² or a BMI ≥ 35 kg/m² in the presence of at least one obesity-related comorbidity who are scheduled to undergo elective primary sleeve gastrectomy will be enrolled. Postoperative follow-up assessments will be performed on postoperative days 1, 2, 3, 30, 90, and 180.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleeve Gastrectomy using Hugo RAS platform | Experimental | Device: Sleeve Gastrectomy using Hugo RAS platformElective 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Previous upper abdominal surgery
- Revisional bariatric surgery
- American Society of Anesthesiologists (ASA) physical status classification ≥ IV
- Oral anticoagulation therapy
- Presence of a ventriculoperitoneal shunt
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleeve Gastrectomy using Hugo RAS platformElective 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 |
Primary outcome
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.
Time frame: From beginning to the end of the Procedure
12 secondary outcomes
Port Placement Time
Time frame: During surgery
Docking Time
Time frame: During surgery
Console Time
Time frame: During surgery
Total Operative Time
Time frame: During surgery
Intraoperative Complications
Time frame: During surgery
Postoperative Complication Rate
Time frame: Within 30 days after surgery
Length of Hospital Stay
Time frame: Assessed up to postoperative day 30
Readmission Rate
Time frame: Within 6 months after surgery
Reoperation Rate
Time frame: Within 6 months after surgery
Postoperative Pain
Time frame: Postoperative day 1, postoperative day 2, and postoperative day 3
Time to Oral Intake and Mobilization
Time frame: Postoperative day 1, postoperative day 2, and postoperative day 3
Health-Related Quality of Life
Time frame: 3 months and 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oliver Mann, Prof Dr principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleeve Gastrectomy using Hugo RAS platform in people with Obesity (BMI > 35) and Obesity (BMI > 35) and Diabetes Mellitus, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Plitzko, Dr (+4915222842144, g.plitzko@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From beginning to the end of the Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.