Bariatric Surgery CandidatePhase 2RoboBarNCT05208138
Feasibility and Safety of Robotic Bariatric Surgery Using the SenhanceTM Surgical System
A Phase 2 study testing Senhance Surgical System from Asensus in people with Bariatric Surgery Candidate, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Evaluating feasibility and safety of the Senhance Surgical System with digital laparoscopy in bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Senhance Surgical System from Asensus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Jan 2022to 15 Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- ≥ 18 years old
- Capable of judgment
- Patient eligible for laparoscopic bariatric surgery according to the SMOB (Swiss Study Group for Morbid Obesity) -Criteria and having a bariatric operation (including Sleeve gastrectomy, Y-Roux gastric bypass, Omega-loop gastric bypass) using SenhanceTM Surgical System
Who cannot join
- < 18 years of age
- Participants incapable of judgment or participants under tutelage
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- No informed consent signed
- Women who are pregnant
- High risk patients (immunosuppression, myopathy, liver cirrhosis, severe heart or lung disease, renal failure)
- Contra-indication for laparoscopic surgery
- Prior upper gastro intestinal tract operations (such as hepatobiliary, pancreatic, gastrooesophageal, anti-reflux, bariatric surgery or splenectomy except cholecystectomy) or open surgery with incision above the umbilicus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Safety of Robotic Bariatric Surgery Using the SenhanceTM Surgical System: a Pilot Study
Evaluating feasibility and safety of the Senhance Surgical System with digital laparoscopy in bariatric surgery.
Read the detailed description
The introduction of laparoscopy in bariatric surgery is considered a milestone to improve postoperative outcomes in terms of less complications and shorter hospital stay. Furthermore, conversion into open surgery is associated with higher postoperative morbidity and mortality in bariatric surgery. Nevertheless, the laparoscopic technique has several drawbacks as lack of tactile feedback, limited degrees of freedom of the laparoscopic instruments, bad depth perception and limited field of view and therefore a flat learning curve.
Senhance Surgical System from Asensus Surgical is an innovative robotic technique which presents haptic feedback, an eyetracker system, microinvasive surgery (with 3mm instruments), reusable instruments and a lower docking time when compared to usual robotic systems.
The use of this new technology has not been systematically analysed in bariatric surgery. Nevertheless, its use is expected to be safe and efficient and may also present some advantages over conventional laparoscopic surgery.
The primary endpoint of the study is the safety of this new robotic platform in bariatric surgery (intraoperative complications, postoperative morbidity, and postoperative mortality). Secondary outcome is the feasibility of this new technology in bariatric surgery (docking time, operation time, conversion rate, length of hospital stay, and rehospitalisation rate).
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Senhance Surgical System from Asensus
- Keywords
- Bariatric Surgery, Robotic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senhance Surgical System from AsensusDevice
Bariatric operation with the Senhance Surgical System
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Bariatric operation with the Senhance surgical system Receives: Device: Senhance Surgical System from Asensus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of intraoperative bleeding using the Senhance Surgical System in bariatric surgery
Number of patients with intraoperative bleeding
Measured: During operation, up to 2 hours
Rate of intraoperative organ lesion using the Senhance Surgical System in bariatric surgery
Number of patients with intraoperative organ lesion
Measured: During operation, up to 2 hours
Rate of procedure interruption using the Senhance Surgical System in bariatric surgery
Number of patients with procedure interruption
Measured: During operation, up to 2 hours
Rate of postoperative bleeding using the Senhance Surgical System in bariatric surgery
Number of patients with postoperative bleeding
Measured: up to 30 days postoperatively
Rate of anastomotic or staple line leakage using the Senhance Surgical System in bariatric surgery
Number of patients with anastomotic or staple line leakage
Measured: up to 30 days postoperatively
Rate of surgical site infection using the Senhance Surgical System in bariatric surgery
Number of patients with surgical site infection (deep or superficial)
Measured: up to 30 days postoperatively
Rate of cardiovascular complication using the Senhance Surgical System in bariatric surgery
Number of patients with a cardiovascular complication
Measured: up to 30 days postoperatively
Rate of respiratory complication using theSenhance Surgical System in bariatric surgery
Number of patients with a respiratory complication
Measured: up to 30 days postoperatively
Rate of thromboembolic complication using the Senhance Surgical System in bariatric surgery
Number of patients with a thromboembolic complication
Measured: up to 30 days postoperatively
Rate of renal complication using the Senhance Surgical System in bariatric surgery
Number of patients with a renal complication
Measured: up to 30 days postoperatively
Secondary outcomes (5)
Feasibility of the Senhance Surgical System in bariatric surgery
Operation time
Measured: During operation, up to 2 hours
Feasibility of the Senhance Surgical System in bariatric surgery
Docking time
Measured: During operation, up to 2 hours
Feasibility of the Senhance Surgical System in bariatric surgery
Conversion rate
Measured: During operation, up to 2 hours
Feasibility of the Senhance Surgical System in bariatric surgery
Length of hospital stay
Measured: at hospital discharge, up to 30 days
Feasibility of the Senhance Surgical System in bariatric surgery
Rehospitalisation rate
Measured: up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start20 Jan 2022
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Why it stopped: leasing of the Senhance system ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single arm, two-stage phase II study
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philipp C Nett, MD, Study director, Inselspital Universitätsspital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208138
- Sponsor's protocol ID
- STD0005853
- Acronym
- RoboBar
- Status last verified
- Nov 2022
- First submitted
- 27 Dec 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Robotic Bariatric Surgery Using the SenhanceTM Surgical System: a Pilot Study
- ClinicalTrials.gov ID
- NCT05208138
- Acronym / sponsor ID
- RoboBar / STD0005853
- Conditions
- Bariatric Surgery Candidate
- Keywords
- Bariatric Surgery, Robotic Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: leasing of the Senhance system ended
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 26 Jan 2022 (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.
Evaluating feasibility and safety of the Senhance Surgical System with digital laparoscopy in bariatric surgery.
Detailed description
The introduction of laparoscopy in bariatric surgery is considered a milestone to improve postoperative outcomes in terms of less complications and shorter hospital stay. Furthermore, conversion into open surgery is associated with higher postoperative morbidity and mortality in bariatric surgery. Nevertheless, the laparoscopic technique has several drawbacks as lack of tactile feedback, limited degrees of freedom of the laparoscopic instruments, bad depth perception and limited field of view and therefore a flat learning curve.
Senhance Surgical System from Asensus Surgical is an innovative robotic technique which presents haptic feedback, an eyetracker system, microinvasive surgery (with 3mm instruments), reusable instruments and a lower docking time when compared to usual robotic systems.
The use of this new technology has not been systematically analysed in bariatric surgery. Nevertheless, its use is expected to be safe and efficient and may also present some advantages over conventional laparoscopic surgery.
The primary endpoint of the study is the safety of this new robotic platform in bariatric surgery (intraoperative complications, postoperative morbidity, and postoperative mortality). Secondary outcome is the feasibility of this new technology in bariatric surgery (docking time, operation time, conversion rate, length of hospital stay, and rehospitalisation rate).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single arm, two-stage phase II study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Senhance Surgical System from AsensusBariatric operation with the Senhance surgical system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- ≥ 18 years old
- Capable of judgment
- Patient eligible for laparoscopic bariatric surgery according to the SMOB (Swiss Study Group for Morbid Obesity) -Criteria and having a bariatric operation (including Sleeve gastrectomy, Y-Roux gastric bypass, Omega-loop gastric bypass) using SenhanceTM Surgical System
Key exclusion criteria (8 listed)
- < 18 years of age
- Participants incapable of judgment or participants under tutelage
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- No informed consent signed
- Women who are pregnant
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 |
|---|---|---|
| Senhance Surgical System from AsensusBariatric operation with the Senhance Surgical System | Device | Intervention |
Primary outcome
Rate of intraoperative bleeding using the Senhance Surgical System in bariatric surgery
Time frame: During operation, up to 2 hours
Number of patients with intraoperative bleeding
Rate of intraoperative organ lesion using the Senhance Surgical System in bariatric surgery
Time frame: During operation, up to 2 hours
Number of patients with intraoperative organ lesion
Rate of procedure interruption using the Senhance Surgical System in bariatric surgery
Time frame: During operation, up to 2 hours
Number of patients with procedure interruption
Rate of postoperative bleeding using the Senhance Surgical System in bariatric surgery
Time frame: up to 30 days postoperatively
Number of patients with postoperative bleeding
Rate of anastomotic or staple line leakage using the Senhance Surgical System in bariatric surgery
Time frame: up to 30 days postoperatively
Number of patients with anastomotic or staple line leakage
Rate of surgical site infection using the Senhance Surgical System in bariatric surgery
Time frame: up to 30 days postoperatively
Number of patients with surgical site infection (deep or superficial)
Rate of cardiovascular complication using the Senhance Surgical System in bariatric surgery
Time frame: up to 30 days postoperatively
Number of patients with a cardiovascular complication
Rate of respiratory complication using theSenhance Surgical System in bariatric surgery
Time frame: up to 30 days postoperatively
Number of patients with a respiratory complication
Rate of thromboembolic complication using the Senhance Surgical System in bariatric surgery
Time frame: up to 30 days postoperatively
Number of patients with a thromboembolic complication
Rate of renal complication using the Senhance Surgical System in bariatric surgery
Time frame: up to 30 days postoperatively
Number of patients with a renal complication
5 secondary outcomes
Feasibility of the Senhance Surgical System in bariatric surgery
Time frame: During operation, up to 2 hours
Feasibility of the Senhance Surgical System in bariatric surgery
Time frame: During operation, up to 2 hours
Feasibility of the Senhance Surgical System in bariatric surgery
Time frame: During operation, up to 2 hours
Feasibility of the Senhance Surgical System in bariatric surgery
Time frame: at hospital discharge, up to 30 days
Feasibility of the Senhance Surgical System in bariatric surgery
Time frame: up to 30 days postoperatively
Results and safety
The study was stopped early (reason given: leasing of the Senhance system ended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Philipp C Nett, MD study director
Inselspital Universitätsspital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Senhance Surgical System from Asensus in people with Bariatric Surgery Candidate, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 4 Nov 2022. 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 Switzerland. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: leasing of the Senhance system ended). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of intraoperative bleeding using the Senhance Surgical System in bariatric surgery (time frame: During operation, up to 2 hours). The study lists 10 primary outcomes in all. 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 4 Nov 2022.