Feasibility and Safety of Robotic Bariatric Surgery Using the SenhanceTM Surgical System: a Pilot Study
Phase: PHASE2
Conditions: Bariatric Surgery Candidate
Sponsor: Insel Gruppe AG, University Hospital Bern

 
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Clinical Investigation Plan (CIP) 
 
Feasibility and safety of robotic bariatric surgery using the SenhanceTM Surgical System: a pilot 
study 
Short Title:  RoboBar Study   
 
Type of investigation: 
Clinical investigation concerning medical devices (MD). 
Categorisation: 
Category A1 
Registration: 
www.ClinicalTrials.gov : follows 
Swiss National Clinical trial Portal : follows  
Identifier: 
Follows (institutional identifier) 
Sponsor-Investigator: 
PD Dr. med. Philipp C. Nett, Leitender Arzt Bariatrische Chirurgie 
Klinik für Viszerale Chirurgie und Medizin 
Inselspital – Universitätsspital Bern 
CH-3010 Bern 
philipp.nett@insel.ch  
Tel.+41 31 632 54 06 
 
Sponsor representative (if the 
Sponsor is not located in 
Switzerland) 
Not applicable 
Medical Device: 
SenhanceTM Surgical System and Instruments from Asensus 
Surgical 
- 
Senhance Cockpit: (01)00815440020309 
- 
Senhance Manipulator Arm: (01)00815440020293 
CIP Version and Date: 
V3.0 26.11.2021 
 
CONFIDENTIAL 
The information contained in this document is confidential and the property of the Sponsor-Investigator. 
The information may not - in full or in part - be transmitted, reproduced, published, or disclosed to others 
than the applicable Competent Ethics Committee(s) and Regulatory Authority(ies) without prior written 
authorisation from the Sponsor except to the extent necessary to obtain informed consent from those 
who will participate in the investigation. 
 
 

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Signature Page(s)  
 
ID number of the 
investigation: 
Investigation ID (follows) 
 
Title: 
Feasibility and safety of robotic bariatric surgery using the 
SenhanceTM Surgical System: a pilot study 
 
 
The Sponsor-Investigator has approved the CIP version 3.0 26.11.2021, and confirms hereby to conduct 
the investigation according to the CIP, the current version of the World Medical Association Declaration 
of Helsinki, ISO14155 norm, ICH-GCP as far as applicable, and the local legally applicable requirements. 
 
Sponsor-Investigator:  
PD Dr. med. Philipp C. Nett, Leitender Arzt Bariatrische Chirurgie 
Klinik für Viszerale Chirurgie und Medizin 
Inselspital – Universitätsspital Bern 
CH-3010 Bern 
philipp.nett@insel.ch  
Tel.+41 31 632 54 06 
 
 
 
Place/Date 
 
Signature 
 
 
 
 

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Table of Contents 
 
SYNOPSIS .............................................................................................................................................. 6 
ABBREVIATIONS ................................................................................................................................... 8 
SUMMARY OF THE REVISION HISTORY IN CASE OF AMENDMENTS .......................................... 10 
INVESTIGATION SCHEDULE .............................................................................................................. 10 
1. 
INVESTIGATION ADMINISTRATIVE STRUCTURE .................................................................... 11 
1.1 
Sponsor-Investigator ................................................................................................................... 11 
1.2 
Co- Investigators ......................................................................................................................... 11 
1.3 
Statistician ("Biostatistician") ....................................................................................................... 11 
1.4 
Laboratory ................................................................................................................................... 11 
1.5 
Monitoring institution ................................................................................................................... 11 
1.6 
Data Safety Monitoring Committee ............................................................................................. 12 
1.7 
Any other relevant Committee, Person, Organisation, Institution ............................................... 12 
2. 
ETHICAL AND REGULATORY ASPECTS .................................................................................. 13 
2.1 
Registration of the investigation .................................................................................................. 13 
2.2 
Categorisation of the investigation .............................................................................................. 13 
2.3 
Competent Ethics Committee (CEC) .......................................................................................... 13 
2.3.1 Reporting duties to the Competent Ethics Committee ........................................................ 13 
2.4 
Competent Authorities (CA) ........................................................................................................ 13 
2.4.1 Reporting duties to the competent authorities .................................................................... 13 
2.5 
Ethical Conduct of the Investigation ............................................................................................ 13 
2.6 
Declaration of interests................................................................................................................ 13 
2.7 
Patient Information and Informed Consent ................................................................................. 14 
2.8 
Subject privacy and confidentiality .............................................................................................. 14 
2.9 
Early termination of the investigation .......................................................................................... 14 
2.10 Clinical investigation plan amendments ...................................................................................... 14 
2.11 Deviation from the Clinical Investigation Plan ............................................................................. 15 
3. 
BACKGROUND AND RATIONALE .............................................................................................. 16 
3.1 
Background and Rationale for the clinical investigation .............................................................. 16 
3.2 
Identification and description of the Investigational Medical Device ........................................... 16 
3.3 
Preclinical Evidence .................................................................................................................... 17 
3.4 
Clinical Evidence to Date ............................................................................................................ 17 
3.5 
Justification for the design of the clinical investigation ................................................................ 17 
3.6 
Explanation for choice of comparator .......................................................................................... 18 
3.7 
Risk evaluation (Risk-to-Benefits rationale) ................................................................................ 18 
3.8 
Justification of the choice of the investigation population ........................................................... 18 
4. 
CLINICAL INVESTIGATION OBJECTIVES ................................................................................. 19 
4.1 
Overall Objective ......................................................................................................................... 19 
4.2 
Primary Objective ........................................................................................................................ 19 
4.3 
Secondary Objectives ................................................................................................................. 19 
4.4 
Safety Objectives ........................................................................................................................ 19 
5. 
CLINICAL INVESTIGATION OUTCOMES ................................................................................... 20 
5.1 
Primary Outcome ........................................................................................................................ 20 
5.2 
Secondary Outcomes .................................................................................................................. 20 
5.3 
Other Outcomes of Interest ......................................................................................................... 20 

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5.4 
Safety Outcomes ......................................................................................................................... 20 
6. 
CLINICAL INVESTIGATION DESIGN .......................................................................................... 21 
6.1 
General clinical investigation design and justification of design ................................................. 21 
6.2 
Methods for minimising bias ........................................................................................................ 21 
6.2.1 Randomisation .................................................................................................................... 21 
6.2.2 Blinding procedures ............................................................................................................ 21 
6.2.3 Other methods for minimising bias ..................................................................................... 21 
6.3 
Unblinding Procedures (Code break) .......................................................................................... 21 
7. 
CLINICAL INVESTIGATION POPULATION ................................................................................. 22 
7.1 
Eligibility criteria ........................................................................................................................... 22 
7.2 
Recruitment and screening ......................................................................................................... 22 
7.3 
Assignment to investigation groups ............................................................................................ 22 
7.4 
Criteria for withdrawal / discontinuation of subjects .................................................................... 22 
8. 
CLINICAL INVESTIGATION INTERVENTION ............................................................................. 23 
8.1 
Identity of the medical device under investigation ...................................................................... 23 
8.1.1 Experimental Intervention (medical device) ........................................................................ 23 
8.1.2 Control Intervention (standard/routine/comparator) ............................................................ 26 
8.1.3 Labelling and Supply (re-supply) ........................................................................................ 26 
8.1.4 Storage Conditions.............................................................................................................. 26 
8.2 
Discontinuation or modifications of the intervention .................................................................... 26 
8.3 
Compliance with clinical investigation intervention ..................................................................... 26 
8.4 
Data Collection and Follow-up for withdrawn subjects ............................................................... 26 
8.5 
Clinical investigation specific preventive measures .................................................................... 27 
8.6 
Concomitant Interventions (treatments) ...................................................................................... 27 
8.7 
Medical Device Accountability ..................................................................................................... 27 
8.8 
Return, Analysis or Destruction of the Medical Device ............................................................... 27 
9. 
CLINICAL INVESTIGATION ASSESSMENTS ............................................................................. 28 
9.1 
Clinical investigation flow chart(s) / table of clinical investigation procedures and assessments 28 
9.2 
Assessments of outcomes .......................................................................................................... 28 
9.2.1 Assessment of primary outcome ......................................................................................... 28 
9.2.2 Assessment of secondary outcomes .................................................................................. 29 
9.2.3 Assessment of other outcomes of interest .......................................................................... 29 
9.2.4 Assessment of safety outcomes ......................................................................................... 29 
9.2.5 Assessments in subjects who prematurely stop the clinical investigation .......................... 30 
9.2.6 Follow-up of the subjects after the regular termination of the clinical investigation ............ 30 
9.3 
Procedures at each visit .............................................................................................................. 30 
9.3.1 Peroperative consultation ................................................................................................... 30 
9.3.2 Operation and Hospital stay 3-4 days ................................................................................. 30 
9.3.3 Postoperative consultation (30 day after the operation) ..................................................... 30 
10. SAFETY ......................................................................................................................................... 32 
10.1 Definition and Assessment of (Serious) Adverse Events and other safety related events ......... 32 
10.2 Adverse events categorization .................................................................................................... 33 
10.3 Documentation and reporting in Medical Device Category C clinical investigations .................. 33 
10.4 Documentation and reporting in Medical Device Category A clinical investigations .................. 33 
10.4.1 Foreseeable adverse events and anticipated adverse device effects ................................ 33 
10.4.2 Reporting of Safety related events...................................................................................... 34 

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10.5 Assessment, notification and reporting on the use of radiation sources ..................................... 35 
11. STATISTICAL METHODS ............................................................................................................. 36 
11.1 Hypothesis ................................................................................................................................... 36 
11.2 Determination of Sample Size ..................................................................................................... 36 
11.3 Statistical criteria of termination of the investigation ................................................................... 36 
11.4 Planned Analyses ........................................................................................................................ 36 
11.4.1 Datasets to be analysed, analysis populations ................................................................... 36 
11.4.2 Primary Analysis ................................................................................................................. 36 
11.4.3 Secondary Analyses ........................................................................................................... 36 
11.4.4 Interim analyses .................................................................................................................. 37 
11.4.5 Deviation(s) from the original statistical plan ...................................................................... 37 
11.5 Handling of missing data and drop-outs...................................................................................... 37 
12. QUALITY ASSURANCE AND CONTROL .................................................................................... 38 
12.1 Data handling and record keeping / archiving ............................................................................. 38 
12.1.1 Case Report Forms ............................................................................................................. 38 
12.1.2 Specification of source data and source documents .......................................................... 38 
12.1.3 Archiving of essential clinical investigation documents ...................................................... 38 
12.2 Data management ....................................................................................................................... 38 
12.2.1 Data Management System ................................................................................................. 38 
12.2.2 Data security, access and back-up ..................................................................................... 39 
12.2.3 Analysis and archiving ........................................................................................................ 39 
12.2.4 Electronic and central data validation ................................................................................. 39 
12.3 Monitoring .................................................................................................................................... 39 
12.4 Audits and Inspections ................................................................................................................ 39 
12.5 Confidentiality, Data Protection ................................................................................................... 40 
12.6 Storage of biological material and related health data ................................................................ 40 
13. PUBLICATION AND DISSEMINATION POLICY.......................................................................... 41 
14. FUNDING AND SUPPORT ............................................................................................................ 42 
14.1 Funding ....................................................................................................................................... 42 
14.2 Other Support .............................................................................................................................. 42 
15. INSURANCE .................................................................................................................................. 42 
16. REFERENCES ............................................................................................................................... 43 
17. APPENDICES ................................................................................................................................ 44 
 
 
 

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SYNOPSIS  
 
Sponsor-Investigator 
Philipp C. Nett, MD 
Title: 
Feasibility and safety of robotic bariatric surgery using the SenhanceTM 
Surgical System: a pilot study 
Short title / 
Investigation ID: 
RoboBar Study  / follows 
Clinical Investigation 
Plan, version and 
date: 
Version 3.0 / 26.11.2021 
Registration: 
www.ClinicalTrials.gov : follows 
Swiss National Clinical trial Portal : follows  
Category and its 
rationale: 
Category A1 
Clinical trial with a medical device representing only minimal risk for the 
investigated subject 
Name of the MD, 
Unique Device 
Identification (UDI), 
name of the 
manufacturer 
SenhanceTM Surgical System and Instruments  from Asensus Surgical 
- 
Senhance Cockpit: (01)00815440020309 
- 
Senhance Manipulator Arm: (01)00815440020293 
Stage of 
development: 
Phase II: Evaluating feasibility and safety of the SenhanceTM Surgical System 
with digital laparoscopy in bariatric surgery.  
Background and 
rationale: 
The introduction of laparoscopy in bariatric surgery in 1993 is considered a 
milestone to improve postoperative outcomes in terms of less complications 
and shorter hospital stay [1]. Furthermore, conversion into open surgery is 
associated with higher postoperative morbidity and mortality in bariatric 
surgery [2]. 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.  
Recently, robotic surgery has been introduced in bariatric surgery manly 
through the Da Vinci robotic system to overcome some of those drawbacks. 
Robotic surgery presents the advantage of a 3-dimensional visualisation with 
high definition, more ergonomics and facilitates some complex laparoscopic 
tasks such as suturing [3, 4]. These advantages are especially relevant in 
bariatric surgery were abdominal obesity is often a cause of uncomfortable and 
tedious position for the surgeon and restrains the exposure of the surgical field. 
SenhanceTM Surgical System from Asensus Surgical is an innovative robotic 
technique which presents, additionally to the above mentioned advantages, 
haptic feedback, an eyetracker system, microinvasive surgery (with 3mm 
instruments), reusable instruments and a lower docking time when compared 
to usual robotic systems[5, 6].  
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. 
Objective(s): 
To evaluate feasibility and safety of SenhanceTM Surgical System in bariatric 
surgery. 

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Outcome(s): 
Primary outcomes (safety): intraoperative complications, postoperative 
morbidity, and postoperative mortality. 
Secondary outcomes (feasibility): Docking time, Operation time, conversion 
rate, length of hospital stay, and rehospitalisation rate. 
 
Design: 
Prospective single arm, two-stage phase II study  
Inclusion / exclusion 
criteria: 
Participants fulfilling all of the following inclusion criteria are eligible for the 
study: 
- 
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 
 
The presence of any one of the following exclusion criteria will lead to exclusion 
of the participant: 
- 
< 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  
Measurements and 
procedures: 
Eligible patients for bariatric surgery are included into the study during the 
outpatient consultation used to plan the bariatric procedure (incl. signature of 
the informed consent + collection of clinicopathological data*). 
Perioperative data** are collected after the operation, on the hospital release 
day and during the postoperative consultation 30 days after surgery.  
 
*Patient’s clinicopathologic characteristics: age, sex, ASA score, BMI, previous 
abdominal surgery (laparoscopic, laparotomy), comorbidity (cardiovascular, 
respiratory, renal, neurological, psychiatric disease, other relevant disease).  
**Perioperative data: type of procedure, docking time, operation time, 
intraoperative complication (bleeding, organ lesion, procedure interruption), 
conversion, postoperative complication at 30 day postoperatively (Clavien-
Dindo Classification + type of complication: postoperative bleeding, 
anastomotic or staple line leakage, surgical site infection, cardiovascular 
complication, respiratory complication, thromboembolic complication, renal 
complication...) and need for re-intervention. Length of hospital stay and 
rehospitalisation rate at 30-day postoperatively.  
 

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Intervention:  
The bariatric procedure will be done using the SenhanceTM Surgical System. 
It is a robotic technology developed by Asensus Surgical aimed to assist in 
the accurate control of laparoscopic instrument for visualization and 
manipulation of tissue (grasping, cutting, blunt and sharp dissection and 
suturing) in laparoscopic and thoracoscopic surgery. This technic is provided 
with haptic feedback, eyetracker system, 3mm instruments and 3-
dimensional visualization. The product bears a CE mark. 
Control intervention 
(if applicable): 
Not applicable 
Number of subjects 
with rationale: 
Treatment group: 
39 patients should be included into the study as calculated for the Simon’s 
two stage design of the study 
 
Duration of the 
investigation: 
12 months 
Investigation 
schedule: 
01.12.2021 First-Participant-In (planned) 
30.11.2022 Last-Participant-Out (planned) 
 
Investigator(s): 
PD Dr. med. Philipp C. Nett, Leitender Arzt Bariatrische Chirurgie 
Klinik für Viszerale Chirurgie und Medizin 
Inselspital – Universitätsspital Bern 
CH-3010 Bern 
philipp.nett@insel.ch  
Tel.+41 31 632 54 06 
  
Investigational Site: 
Single centre, Inselspital (University hospital Bern) 
Statistical 
considerations: 
The primary endpoint of our study is the safety of this new robotic platform in 
bariatric surgery. Therefore our study is designed as a single arm, two-stage 
phase II study with a stopping rule for safety using the Simon’s two-stage 
design. Considering that conventional laparoscopic bariatric procedures 
present a complication rate around 10%, we set the maximum acceptable 
threshold of complication at 25%.  Type I error is assumed to be 0.05 and Type 
II error 0.8. Therefore a sample size of 39 patients is needed with an interim 
analysis at 22 patients. The stopping rule is 5 or more events at the interim 
analysis and robotic surgery is considered safe if less than 6 events occurred. 
Baseline characteristics and perioperative data will be presented as medians 
(IQ-range) for continuous variables or frequencies (percentages) for 
categorical variables. For statistical analysis SPSS Version 25 will be used. 
The docking time and operation time will be represented as a visual graphic 
with its evolution over time.  
Compliance 
statement: 
This investigation will be conducted in compliance with the CIP, the current 
version of the Declaration of Helsinki, ISO14155, ICH-GCP (as far as 
applicable) as well as all national legal and regulatory requirements.  
 
ABBREVIATIONS 
Provide a list of abbreviations used in the CIP – to be completed/adapted 
 
AE 
Adverse Event  

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ADE 
ASA score 
Adverse Device Effect 
American Society of Anesthesiology 
ASADE 
Anticipated Serious Adverse Device Effect 
ASR 
BMI 
Annual Safety Report 
Body mass index 
CA 
Competent Authority (e.g. Swissmedic) 
CEC 
Competent Ethics Committee 
CIP 
Clinical investigation plan 
ClinO 
Ordinance on Clinical Trials in Human Research (in German KlinV, in French Oclin, 
in Italian OSRUm) 
ClinO-MD 
Ordinance on Clinical Trials with Medical Devices (in German: KlinV-Mep, in French: 
Oclin-Dim, in Italian: OSRUm-Dmed) 
CRF 
Case Report Form (pCRF paper CRF; eCRF electronic CRF) 
DD 
Device Deficiency 
DMC / DSMC 
Data Monitoring Committee, Data Safety Monitoring Committee 
Ho 
Null hypothesis 
H1 
Alternative hypothesis 
HRA 
Federal Act on Research involving Human Beings (in German: HFG, in French: 
LRH, in Italian: LRUm) 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICH-GCP 
International Council for Harmonisation – guidelines of Good Clinical Practice 
IFU 
Instruction For Use 
ISF 
Investigator Site File 
ISO 
International Organisation for Standardisation 
ITT 
Intention to treat 
MedDO 
Medical Devices Ordinance (in German: MepV, in French: Odim, in Italian: Odmed)
MD 
Medical Device  
MDR 
Medical Device Regulation (EU) 2017/745 of 5 April 2017 
PI 
Principal Investigator 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SDV 
Source Data Verification  
SNCTP 
Swiss National Clinical Trials Portal 
SOP 
Standard Operating Procedure 
USADE 
Unanticipated Serious Adverse Device Effect 
 
 

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SUMMARY OF THE REVISION HISTORY IN CASE OF AMENDMENTS 
Not applicable 
 
INVESTIGATION SCHEDULE 
Study Periods 
 
Screening 
Intervention Period 
In-hospital follow-up 
Follow-up 
Visit 
1 
2 
3 
4 
Time (day) 
-5/14 
0 
2 
30 
Patient Information and 
Informed Consent 
x 
 
 
 
Demographics 
x 
 
 
 
Medical History 
x 
 
 
 
In- /Exclusion Criteria 
 
x 
 
 
Physical Examination 
 
 
x 
x 
Vital Signs 
 
x 
x 
 
Laboratory Tests 
 
 
x 
 
Pregnancy Test 
 
x 
 
 
Operation with use of Medical 
Device 
 
x 
 
 
Primary Variables 
 
x 
x 
x 
Secondary Variables 
 
x 
x 
 
Adverse Events 
 
x 
x 
x 
 
 
 

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1. INVESTIGATION ADMINISTRATIVE STRUCTURE  
1.1 Sponsor-Investigator  
PD Dr. med. Philipp C. Nett, Leitender Arzt Bariatrische Chirurgie 
Klinik für Viszerale Chirurgie und Medizin 
Inselspital – Universitätsspital Bern 
CH-3010 Bern 
philipp.nett@insel.ch   
Tel.+41 31 632 54 06 
 
1.2 Co- Investigators 
Dr. med. et scient. med.  Gian Andrea Prevost  
Oberarzt Viszerale Chirurgie 
Klinik für Viszerale Chirurgie und Medizin 
Inselspital – Universitätsspital Bern 
CH-3010 Bern 
+41 31 632 60 68 
gianandrea.prevost@insel.ch  
 
Dr. med. Pauline Aeschbacher 
Assistenzärztin Viszeral Chirurgie 
Klinik für Viszerale Chirurgie und Medizin 
Inselspital – Universitätsspital Bern 
CH-3010 Bern 
+41 31 632 59 00 
pauline.aeschbacher@insel.ch   
 
1.3 Statistician ("Biostatistician")  
CTU Bern Dr. Brigitta Gahl 
University of Bern (Clinical Trials Unit) 
MIttelstrasse 43 
3012 Bern 
 +41 031 684 33 72 
 
1.4 Laboratory 
Not applicable 
 
1.5 Monitoring institution 
Studynurse 
Klinik für Viszerale Chirurgie und Medizin 
Inselspital – Universitätsspital Bern 
CH-3010 Bern 
+41 31 632 59 00 

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1.6 Data Safety Monitoring Committee 
Not applicable 
 
1.7 Any other relevant Committee, Person, Organisation, Institution  
Not applicable 
 
 
 

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2. ETHICAL AND REGULATORY ASPECTS  
The final positive decision of the CEC on the conduct of the investigation will be made and given in 
writing to the Sponsor before the investigation can start. 
 
2.1 Registration of the investigation 
The study will be registered in ClinicalTrials.gov and in the Swiss National Clinical trial Portal (SNCTP 
via BASEC). 
 
2.2 Categorisation of the investigation 
Category A1: The treatment with SenhanceTM Surgical System represents only minimal risk for the 
investigated subject.  
SenhanceTM Surgical System is a medical device in conformity with Medical Device Directive 
93/42/EEC and subsequent amendments and integrations.  
 
2.3 Competent Ethics Committee (CEC)  
The Sponsor-Investigator will submit the investigation to the CEC and obtain ethical committee approval 
before the start of the investigation. The Co-investigators ensure that approval from the CEC is obtained 
and filed in the Investigator site file before the investigation starts.  
2.3.1 
Reporting duties to the Competent Ethics Committee 
All changes in the research activity and all unanticipated problems involving risks to humans, planned 
or premature study end and the final report are reported to the CEC within the allowed time frames.   
No changes to the protocol will be made without prior sponsor-investigator and CEC approval, except 
where necessary to eliminate apparent immediate hazards to study participants. 
Amendments are reported according to Art. 15 ClinO-MD (see also 2.10). 
The regular or premature end of the investigation as well as the interruption of the investigation is 
reported to the CEC within 15 days (within 24 hours if it is due to security reasons) (Art. 36 ClinO-MD). 
The reasons for a premature end or an interruption have to be explained.  
A final report shall be submitted within one year after the regular end of the investigation and within 3 
months after a premature end of the investigation (Art. 37 ClinO-MD).  
 
2.4 Competent Authorities (CA)  
2.4.1 
Reporting duties to the competent authorities 
Not applicable 
 
2.5 Ethical Conduct of the Investigation  
The investigation will be carried out according to the CIP and with principles enunciated in the current 
version of the Declaration of Helsinki, the European Regulation on medical devices 2017/745 (MDR), 
the Norms ISO14155 and ISO14971, the ICH-guidelines of Good Clinical Practice (GCP) as applicable, 
the Swiss Human Research Act (HRA) and its Ordinances and Swiss regulatory authority’s 
requirements. The CEC will receive the Annual Safety Report (ASR) and interim reports and be notified 
about investigation stop/end in agreement with local requirements.  
 
2.6 Declaration of interests  
The Sponsor-Investigator (Philipp Nett) and the Co-Investigators (Gian Andrea Prevost and Pauline 
Aeschbacher) declare no conflict of interest.  

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2.7 Patient Information and Informed Consent 
The Investigators explain to each subject the nature of the investigation, its purpose, the procedures 
involved, the expected duration, the potential risks and benefits and any discomfort it may entail. Each 
subject is informed that the participation in the investigation is voluntary and that he/she may withdraw 
from the investigation at any time and that withdrawal of consent will not affect his/her subsequent 
medical assistance and treatment. The subjects are informed that he/she can ask any question, and 
consult with family members, friends, their treating physicians or other experts before deciding about 
their participation in the investigation. Enough time is given to the subjects 
The subjects are informed that authorised individuals other than their treating physician may examine 
his/her medical records. 
All subjects are given a subject information sheet and a consent form describing the investigation and 
providing sufficient information for the subjects to make an informed decision about their participation in 
the investigation. The enrolment will be performed during the outpatient consultation used to plan the 
bariatric procedure. The bariatric procedure will be done at least five days after this consultation, and 
patients can until then retract their consent if they do not want to participate in this study. No participant 
will be included in an emergency situation.  
The formal consent of a subject, using the approved consent form, is obtained before the subject is 
submitted to any investigation procedure.  
The subject should read, understand, and voluntarily agree before signing and dating the informed 
consent form, and is given a copy of the signed document. The consent form is signed and dated by the 
subject and the Co-Investigators (or her/his designee). The signed consent form it is retained as part of 
the investigation records. 
 
2.8 Subject privacy and confidentiality  
The Sponsor-Investigator and Co-Investigators affirm and uphold the principle of the subjects’ right to 
privacy and that they shall comply with applicable privacy laws. Especially, anonymity of the subjects 
shall be guaranteed when presenting the data at scientific meetings or publishing them in scientific 
journals.  
Individual subject medical information obtained as a result of this investigation is considered confidential 
and disclosure to third parties is prohibited.  
Subject confidentiality will be further ensured by utilising subject identification code numbers to 
correspond to treatment data in the computer files. 
The Investigators will permit IEC review and investigation-related monitoring, providing direct access 
to source data/documents. 
For data verification purposes, a CEC may require direct access to parts of the medical records relevant 
to the investigation, including subjects’ medical history. 
 
2.9 Early termination of the investigation 
The Sponsor-Investigator may terminate the investigation prematurely according to certain 
circumstances, for example: 
 
ethical concerns, 
 
insufficient subject recruitment, 
 
when the safety of the subjects is doubtful or at risk, respectively, 
 
alterations in accepted clinical practice that make the continuation of the investigation unwise,  
 
early evidence of benefit or harm of the experimental intervention. 
 
2.10 Clinical investigation plan amendments 
Substantial amendments are only implemented after approval by the CEC (Art. 15 ClinO-MD). The use 
of waivers from the CIP is prohibited (Annex XV, Chapter 2, Art. 3.10 MDR). 

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Under emergency circumstances, deviations from the CIP to protect the rights, safety and well-being of 
the subjects may proceed without prior approval by the Sponsor-Investigator and the CEC. Such 
deviations shall be documented and reported to the Sponsor and the CEC within 2 days (Art. 34 ClinO-
MD). 
All non-substantial amendments are communicated to the CEC together with the Annual Safety Report 
(ASR) (Art. 15 ClinO-MD), as soon as possible (Art. 20 ClinO-MD). The ASR shall include any deviations 
from the CIP that may have affected the rights, safety or well-being of the subject or the scientific integrity 
of the investigation (ISO14155). 
 
2.11 Deviation from the Clinical Investigation Plan 
The use of waivers from the CIP is prohibited (Annex XV, Chapter 2, Art. 3.10 MDR). 
The investigator is not allowed to deviate from the CIP, except as specified in 2.10. 
 
 
 

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3. BACKGROUND AND RATIONALE  
3.1 Background and Rationale for the clinical investigation 
The introduction of laparoscopy in bariatric surgery in 1993 is considered to be a milestone to improve 
postoperative outcomes in terms of complications and length of hospital stay [1]. Furthermore, 
conversion into open surgery is associated with higher postoperative morbidity and mortality in bariatric 
surgery[2]. 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. 
Recently robotic surgery has been introduced in bariatric surgery manly through the Da Vinci robotic 
system to overcome some of those drawbacks. Robotic surgery presents the advantage of a 3-
dimensional visualization with high definition, more ergonomics, and facilitates some complex 
laparoscopic tasks such as suturing [3, 4]. These advantages are especially relevant in bariatric surgery 
were abdominal obesity is often a cause of uncomfortable and tedious position for the surgeon and 
restrains the exposure of the surgical field. 
Several studies compare outcomes between laparoscopic and robotic intervention in bariatric surgery. 
Metanalysis shows that robotic bariatric surgery is associated with longer operative time and higher 
hospital costs when compared to laparoscopic bariatric surgery. However, comparable incidence of 
postoperative complications, postoperative mortality, conversion, reoperation, and length of hospital 
stay is reported [7-10]. Weight reduction also seems to be similar between laparoscopic and robotic 
bariatric surgery [7].  
SenhanceTM Surgical System from Asensus Surgical is an innovative robotic technic that presents, 
additionally, to the above mentioned advantages of robotic surgery: haptic feedback, an eye-tracker 
system, micro-invasive surgery (with 3m instrument), reusable instrument and a lower docking time 
when compared to usual robotic systems [5, 6].  
This new technology has not yet been systematically tested in bariatric surgery. However, its use is 
expected to be safe and efficient and the new robotic platform may also present some advantages over 
laparoscopic surgery as well as other robotic technology. This new technology has already been proved 
safe and feasible in the field of gynecology, urology, colorectal surgery and general surgery [5, 11-15]. 
This platform has also been used in upper gastrointestinal surgery [16-18]. Furthermore, 
cholecystectomies performed with the SenhanceTM Surgical robotic platform on patients with BMI above 
48 kg/m2 have already been reported in the literature as feasible [15]. A pilot study was also performed 
for hysterectomy on obese patients (BMI up to 38kg/m2), and sigmoidectomy was reported for patients 
up to 38 kg/m2 [11, 19]. Therefore we believe that the SenhanceTM Surgical platform is also safe and 
efficient in bariatric surgery. 
The purpose of this study is to analyze the feasibility and safety of this new robotic plateform in bariatric 
surgery, which differs well from the Da Vinci robot of Intuitive Surgical with which all studies on robotic 
surgery in bariatrics have been performed. We believe that robotic surgery with a platform such as 
Asensus Surgical System allows a better ergonomics of the surgery while bringing a better precision in 
his gestures. This could also reduce postoperative pain and promote a faster recovery. The precision of 
the surgical gesture and the increased comfort of the surgeon could also positively influence the 
postoperative morbidity and the operative time. 
 
 
3.2 Identification and description of the Investigational Medical Device 
The SenhanceTM Surgical System with Digital Laparoscopy from Asensus Surgical (formerly 
TransEnterix: TransEnterix Announces Name Change to Asensus Surgical and Introduces a New 
Category of Surgery, Performance-Guided Surgery | TransEnterix, Inc.).  
Manufactured by:  
Asensus Surgical Italia S.r.l. 
Viale dell’Innovazione, 3 
20126 Milano (MI), Italy 
From Senhance Surgical System User Manual:  
“The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments 
for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp 

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dissection, approximation, ligation, electrosurgery, suturing, mobilization, retraction, and sealing of 
vessels up to and including 5 mm in diameter in laparoscopic and thoracoscopic surgery. The system 
is indicated for adult and pediatric use. It is intended for use by trained physicians in an operating room 
environment in accordance with the Instructions for Use. Use of the device is limited to patients with a 
weight equal to or above 10 kg, who are suitable to be subjected to a conventional endoscopic technique. 
In obese patients, stressed instruments may have a curved shaft. This curvature may cause abnormal 
forces on the haptic handles.  
With obese patients, considering the loss of instrument range of motion, the movement may be 
uncomfortable. In some cases, the anatomical characteristics of the patient might make it necessary to 
use manual instruments. 
In obese patients, it may be useful to repeat the docking in positions where the surgical instruments are 
stressed in order to reduce the forces that develop around the trocar and are transmitted to the handle. 
This procedure can only help, but not guarantee, correct transmission of the forces to the tip of the 
instrument. In fact, the feedback force to the handle increases proportional to the increase of the 
instrument inclination with respect to the angle at which you did the docking search. Therefore, this 
procedure can help only partially and may not be sufficient. 
(…) 
The Senhance system is contraindicated for use where endoscopic or laparoscopic surgical techniques 
are contraindicated. 
(…) 
Only physicians having adequate training and experience with endoscopic techniques should perform 
laparoscopic procedures with the Senhance system. Consult medical literature regarding techniques, 
complications, and hazards before performing any laparoscopic procedure. Only surgeons and staff 
who have received training provided by Asensus Surgical in the use of the Senhance system should 
use the system. Training provided by Asensus Surgical is limited to the use of the Senhance system 
and does not replace the necessary medical training and experience required to perform surgery. This 
device is intended to be used by: • Surgeons who have developed adequate robotic surgery skills to 
perform the tasks associated with each procedure and who have received specific training provided by 
Asensus Surgical in the use of this system. • Bedside scrubbed OR staff who are properly qualified to 
assist surgeons in the area of roboticallyassisted laparoscopic surgery and who have received specific 
training provided by Asensus Surgical in the use of this system. • OR staff (scrubbed and circulating) 
who are properly qualified to assist surgeons with preparing the sterile field and equipment for 
robotically-assisted laparoscopic surgery and who have received specific training provided by Asensus 
Surgical in the use of this system. Training is always offered upon installation of the device. 
(…) 
This device is covered by a declaration of conformity with Medical Device Directive 93/42/EEC or 
European Medical Device Regulation 2017/745 and subsequent amendments and integrations. The 
device is also covered by Radio Equipment Directive 2014/53/EU and RoHS 2 Directive 2011/65/EU. 
As required by law, the original of these declarations are available at Asensus Surgical Italia S.r.l.” 
 
3.3 Preclinical Evidence 
Not applicable 
3.4 Clinical Evidence to Date 
This new technology has already been proved safe and efficient in the field of gynecology, urology, 
colorectal surgery and general surgery [5, 11-15]. This platform has also been used in upper 
gastrointestinal surgery [16-18]. Furthermore, cholecystectomies performed with the SenhanceTM 
Surgical robotic platform on patients with BMI above 48 kg/m2 have already been reported in the 
literature as feasible [15]. A pilot study was also performed for hysterectomy on obese patients (BMI up 
to 38kg/m2), and sigmoidectomy was reported for patients up to 38 kg/m2 [11, 19].  
3.5 Justification for the design of the clinical investigation  
Robotic surgery presents the advantage of better visualization with high definition, more ergonomics, 
and facilitates some complex laparoscopic tasks such as suturing [3, 4]. These advantages are 
especially relevant in bariatric surgery were abdominal obesity is often a cause of uncomfortable and 

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tedious position for the surgeon and restrains the exposure of the surgical field. 
Our study will evaluate the feasibility and safety of SenhanceTM Surgical System in bariatric surgery at 
a single center. Until now, this robotic system has not been investigated in bariatric surgery. The first 
step is to evaluate its feasibility and safety. Therefore, we propose a prospective pilot study during the 
introduction of this robot in our clinic. The aim initially is to analyze the feasibility and safety of this 
robot with a limited number of patients and this in a limited time to be able to highlight, if this new 
technology does not represent a risk for the patient in comparison to a conventional laparoscopic 
surgery. Therefore we plan to perform a prospective open observational single-center study with the 
advantage of less bias and confounding factors than in a retrospective study. To achieve a 
reasonable number of participants and to minimize selection bias we plan to offer robotic operation to 
all eligible patients. In view of the lack of data on this robot in bariatric surgery, a power analysis is not 
feasible. However, we have opted for a Simon’s two stage design and thus perform an interim 
analysis with a stopping rule. 
A randomized controlled trial with conventional laparoscopic is not yet feasible as we have to evaluate 
the feasibility and safety of this procedure first, as we recently introduced it in our centre. However 
subsequently and according to the results of this first study, a randomized study with a larger number 
of patients will be necessary to evaluate more precisely its outcome compared to bariatric surgery by 
conventional laparoscopy. 
We started to operate with this new robotic platform on the 28.06.2021. On the planned starting date 
of the trial (01.12.2021) we expect still to be in the learning curve.  
 
 
3.6 Explanation for choice of comparator 
Not applicable 
3.7 Risk evaluation (Risk-to-Benefits rationale)  
Our study will analyze the safety of the use of the robotic platform of Asensus in bariatric surgery and 
will identify potential risks inherent to this technology.  Possible adverse effects specific to the 
SenhanceTM Surgical System are the same as in traditional laparoscopic surgery.  
The most common complications after bariatric surgery are: anastomotic or staple line leakage, 
postoperative bleeding, pulmonary complications, thromboembolic complications and surgical site 
infection. We expect no adverse event specifically related to SenhanceTM Surgical System that is not 
also part of classic laparoscopic bariatric surgery’s complication. This study aims to observe the rate of 
these complications in robotic surgery compared to the laparoscopic technic. For other robotic platforms, 
literature reports a similar rate of postoperative morbidity and mortality between robotic and laparoscopic 
bariatric surgery [9, 21]. Thus the risks associated with the use of this robotic platform are expected to 
be similar to conventional laparoscopic bariatric surgery. 
The potential benefits of this technology are a better postoperative outcome especially in terms of 
postoperative pain due to a better precision in the surgical gesture and a better ergonomics of the 
surgeon. 
3.8 Justification of the choice of the investigation population  
All patients eligible for a bariatric procedure meeting the inclusion criteria will be included in our study. 
The indication for the bariatric procedure is made according to the SMOB (Swiss Swiss Study Group for 
Morbid Obesity) -Criteria. High risk patients with relevant co-morbidities will not be included in our study. 
It is known that these patients are prompt to higher perioperative morbidity and mortality. However, the 
benefit of weight loss will present a relevant benefit to the course of their disease. Therefore bariatric 
procedures are not contraindicated in those cases. However, we believe that the introduction of the 
robotic system should not be experienced in these patients. 
Patients under 18 years of age, incapable of judgment or under tutelage, will not be included in our 
study.   
There will be no emergency enrolment of patients as bariatric surgery is usually performed as elective 
surgery.   
 

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4. CLINICAL INVESTIGATION OBJECTIVES 
4.1 Overall Objective 
This prospective study is performed to evaluate the feasibility and safety of the use of 
SenhanceTMSurgical System in bariatric surgery.  
4.2 Primary Objective 
The safety of the use of the SenhanceTM Surgical System will be evaluated by monitoring intraoperative 
and postoperative complications, as well as postoperative mortality. 
4.3 Secondary Objectives 
The feasibility will be evaluated by monitoring the docking time, operation time, conversion rate (to 
conventional laparoscopy and open surgery), length of hospital stay and rehospitalisation rate. 
4.4 Safety Objectives 
See Chapter 4.2 
 
 

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5. CLINICAL INVESTIGATION OUTCOMES  
5.1 Primary Outcome 
The primary outcome will evaluate the safety of the use of the SenhanceTM Surgical System in bariatric 
surgery.  
Intraoperative complications such as bleeding, organ lesion, and procedure interruption will be 
monitored during the operation and reported postoperatively.  
Postoperative complications and re-operation will be reported at discharge and at the 30-days follow up 
control. Complications will be classified according to its gravity by the Clavien-Dindo classification and 
by its type (postoperative bleeding, anastomotic or staple line leakage, surgical site infection, 
cardiovascular 
complication, 
respiratory 
complications, 
thromboembolic 
complication, 
renal 
complication...). 
30-day postoperative mortality (= Clavien Dindo grade V) will be reported at discharge and at the 
planned 30-day-checkup.  
5.2 Secondary Outcomes 
As secondary outcomes feasibility of the use of the SenhanceTM Surgical System in bariatric surgery 
will be evaluated. 
Docking time and operation time, as well as conversion rate (into laparoscopic or open surgery), will be 
reported after the operation. This data will provide us some indirect information about the feasibility of 
such procedures.  
The length of hospital stay will be reported at the discharge of the patient and the rehospitalisation rate 
at the 30-days follow up. 
5.3 Other Outcomes of Interest 
Not Applicable 
5.4 Safety Outcomes 
See paragraph 5.1 Primary Outcome. 
 
 

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6. CLINICAL INVESTIGATION DESIGN  
6.1 General clinical investigation design and justification of design  
Our study will evaluate the feasibility and safety of SenhanceTM Surgical System in bariatric surgery at 
a single center. Therefore we plan to perform a prospective open observational single-center study with 
the advantage of less bias and confounding factors than in a retrospective study. To achieve a 
reasonable number of participants and to minimize selection bias we plan to offer robotic operation to 
all eligible patients. A randomized controlled trial with conventional laparoscopic is not yet feasible as 
we have to evaluate the feasibility and safety of this procedure first, as we recently introduced it in our 
centre.  
The robot was introduced in June 2021 in our clinic and the first bariatric operation was performed on 
28.06.2021. Due to a delay of our application to the CEC because of the new application procedure for 
medical devices, the approval for our study will come after the first operated patients. Nevertheless, 
deduced from other teams evaluating robotic operations we believe to still be in the learning curve at 
the beginning of the study. 
No blinding is possible in our study. We plan to include 39 participant in our study which will be operated 
with our robot. The inclusion period will last 12 months and the follow-up 30 days. 
6.2 Methods for minimising bias  
 
6.2.1 
Randomisation  
Not applicable 
6.2.2 
Blinding procedures  
Not applicable 
 
6.2.3 
Other methods for minimising bias  
For minimization of selection bias, all consecutive patients eligible for laparoscopic bariatric surgery and 
meeting the inclusion criteria will be offered to participate in this study and will be prospectively included 
in the study.  
6.3 Unblinding Procedures (Code break)  
Withdrawal of informed consent will lead to participant’s exclusion from the study.  
Study or routine procedures will be stopped if safety concerns are raised.  
 

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7. CLINICAL INVESTIGATION POPULATION  
7.1 Eligibility criteria  
Intervention group (robotic surgery): 
Subjects fulfilling all of the following inclusion criteria are eligible for the investigation: 
 Informed Consent signed by the subject 
 ≥ 18 years old 
 Capable of judgment 
 Patient eligible for laparoscopic bariatric surgery according to the SMOB-Criteria and having a 
bariatric operation (including Sleeve gastrectomy, Y-Roux gastric bypass, Omega-loop gastric 
bypass) using SenhanceTM Surgical System 
 
The presence of any one of the following exclusion criteria will lead to the exclusion of the subject 
 
< 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 GI operation (such as hepatobiliary, pancreatic, gastrooesophageal, anti-reflux or 
bariatric surgery or splenectomy except cholecystectomy) or open surgery with incision above 
the umbilicus  
7.2 Recruitment and screening  
Participants are recruited by the sponsor-investigator or the co-investigators present at the 
preoperative consultation. 
For the female patient with potential pregnancy, a pregnancy-test will be performed on the day of the 
operation upon arrival at the hospital (see Chapter 9.3.2). Otherwise, no specific diagnostic 
investigations or screening is required for the study. 
Patients meeting the inclusion criteria, in the absence of exclusion criteria, will be enrolled in our study. 
No payment or compensation will be given to study participants. 
 
7.3 Assignment to investigation groups  
Not applicable 
 
7.4 Criteria for withdrawal / discontinuation of subjects  
Participants can, at any time of the study and for any reason, withdraw their informed consent in verbal 
or written form. This withdrawal will lead to participant’s exclusion from the study.  
Study or routine procedures will be stopped if safety concerns are raised.  
 

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8. CLINICAL INVESTIGATION INTERVENTION  
8.1 Identity of the medical device under investigation  
8.1.1 
Experimental Intervention (medical device) 
We plan to perform Sleeve gastrectomy, Y-Roux Gastric bypass and Omega-loop gastric bypass with 
the SenhanceTM Surgical System.  
According to our approach in laparoscopic bariatric surgery access to the intraabdominal space will be 
performed with a 12 mm self-cutting optical trocar under direct vision, which offers the visualization of 
different tissue layers to guarantee a safe entry to the intra-abdominal space. Pneumoperitoneum will 
be set to 12-15 mmHg. The following trocars will be placed under visual control. Placement and 
introduction of the robotic arm will be done by a trained surgeon or a trained surgical nurse under the 
supervision of the primary surgeon.  
The planned procedure will be performed with the SenhanceTM robotic system and, if required, assisted 
laparoscopically, for example, for the use of suction/irrigation devices, endoscopic staplers or for better 
exposure (liver retractor).   
At the end of the procedure, the trocars will be retracted under visual control, and the skin closed with 
a skin stapler. As usual, in bariatric surgery in our center, abdominal wall closure will not be performed. 
The SenhanceTM robotic system will be used according to the manual instruction (see below). The 
operator and the assistant at the table have been trained before using the robot by Asensus Surgical (2 
days of dry lab and 1 day of wet lab). A representative of Asensus Surgical is also present during the 
intervention in the operating room to supervise and offer technical support if necessary. 
 
From Senhance Surgical System User Manual:  
“The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments 
for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp 
dissection, approximation, ligation, electrosurgery, suturing, mobilization, retraction, and sealing of 
vessels up to and including 5 mm in diameter in laparoscopic and thoracoscopic surgery. The system 
is indicated for adult and pediatric use. It is intended for use by trained physicians in an operating room 
environment in accordance with the Instructions for Use. Use of the device is limited to patients with a 
weight equal to or above 10 kg, who are suitable to be subjected to a conventional endoscopic technique. 
In obese patients, stressed instruments may have a curved shaft. This curvature may cause abnormal 
forces on the haptic handles.  
With obese patients, considering the loss of instrument range of motion, the movement may be 
uncomfortable. In some cases, the anatomical characteristics of the patient might make it necessary to 
use manual instruments. 
In obese patients, it may be useful to repeat the docking in positions where the surgical instruments are 
stressed in order to reduce the forces that develop around the trocar and are transmitted to the handle. 
This procedure can only help, but not guarantee, correct transmission of the forces to the tip of the 
instrument. In fact, the feedback force to the handle increases proportional to the increase of the 
instrument inclination with respect to the angle at which you did the docking search. Therefore, this 
procedure can help only partially and may not be sufficient. 
(…) 
The Senhance system is contraindicated for use where endoscopic or laparoscopic surgical techniques 
are contraindicated. 
(…) 
Only physicians having adequate training and experience with endoscopic techniques should perform 
laparoscopic procedures with the Senhance system. Consult medical literature regarding techniques, 
complications, and hazards before performing any laparoscopic procedure. Only surgeons and staff 
who have received training provided by Asensus Surgical in the use of the Senhance system should 
use the system. Training provided by Asensus Surgical is limited to the use of the Senhance system 
and does not replace the necessary medical training and experience required to perform surgery. This 
device is intended to be used by: • Surgeons who have developed adequate robotic surgery skills to 
perform the tasks associated with each procedure and who have received specific training provided by 
Asensus Surgical in the use of this system. • Bedside scrubbed OR staff who are properly qualified to 
assist surgeons in the area of roboticallyassisted laparoscopic surgery and who have received specific 

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training provided by Asensus Surgical in the use of this system. • OR staff (scrubbed and circulating) 
who are properly qualified to assist surgeons with preparing the sterile field and equipment for 
robotically-assisted laparoscopic surgery and who have received specific training provided by Asensus 
Surgical in the use of this system. Training is always offered upon installation of the device. 
(…) 
This device is covered by a declaration of conformity with Medical Device Directive 93/42/EEC or 
European Medical Device Regulation 2017/745 and subsequent amendments and integrations. The 
device is also covered by Radio Equipment Directive 2014/53/EU and RoHS 2 Directive 2011/65/EU. 
As required by law, the original of these declarations are available at Asensus Surgical Italia S.r.l.” 
 
 
 

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From Senhance Surgical System User Manual, For a complete list of SenhanceTM instrument please 
see the Appendix: Senhance Surgical System User Manual 
 
8.1.2 
Control Intervention (standard/routine/comparator)  
Not applicable 
 
8.1.3 
Labelling and Supply (re-supply)  
Not applicable 
8.1.4 
Storage Conditions  
Not applicable 
8.2 Discontinuation or modifications of the intervention 
Conversion from a robotic procedure to a laparoscopic procedure can be done for the following reason: 
 
Technical problem with the robotic system which does not prevent safe use of the laparoscopic 
technic 
 
Surgeon choice: at any time of the operation the surgeon can decide to perform a conversion 
in laparoscopy if he esteems the use of the robotic platform not appropriate or too risky 
  
 Conversion from a robotic procedure to an open procedure can be done for the following reason: 
 
Technical problem with the robotic system which also prevents a safe use of the laparoscopic 
technic 
 
Surgeon choice: at any time of the operation the surgeon can decide to perform a conversion 
in open surgery if he esteems the use of the robotic platform not appropriate or too risky 
 
Anesthesiological reason: if the patient does not tolerate the pneumoperitoneum  
 
Each conversion to laparoscopic or open surgery will be reported in the secondary outcome.  
 
8.3 Compliance with clinical investigation intervention  
Not applicable 
8.4 Data Collection and Follow-up for withdrawn subjects  
Participants can, at any time of the study and, for any reason, withdraw their informed consent in verbal 
or written form. This withdrawal will lead to participant’s exclusion from the study.  

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If the bariatric operation is already performed, the follow-up will be performed as usually done in our 
bariatric center (with clinical control at 1, 3, 6, and 12 months during the first year, then each 6 to 12 
months during the following years). The clinicopathological data and outcome until withdraw will be 
collected for safety reasons and will be included in the study. 
If the bariatric operation has not yet been performed, but the patient still wants to benefit from a bariatric 
procedure, bariatric procedure will be performed by laparoscopic technique and the follow-up will be 
performed in our bariatric center as usual. The clinical data collected before withdrawal will be included 
in the study. 
If the bariatric operation has not yet been performed, and the patient does not wish to benefit from it, he 
will be redirected to a conservative weight loss program according to the situation. The clinical data 
collected prior to the withdrawal will be used in the study. 
The medical follow-up of withdrawn subjects, or of subjects that drop out from the investigation 
prematurely is described in chapter 9.2.5 and chapter 9.2.6.  
No further data is collected after patients’ withdrawal. Health-related personal data will be stored in an 
anonymized manner after completion of data evaluation. 
 
8.5 Clinical investigation specific preventive measures 
No specific preventive measures has to be taken during the study that is not also recommended for 
standard bariatric procedure such as cessation of therapeutic anticoagulation.  
8.6 Concomitant Interventions (treatments)  
Not applicable 
 
8.7 Medical Device Accountability  
Not applicable 
8.8 Return, Analysis or Destruction of the Medical Device  
The majority of the instruments used are reusable after sterilization. The rest of the instruments like 
sterile draping or single-use instruments will be disposed.  
In case of device deficiencies, including malfunction, usability issues, or inadequacy in the information 
supplied by the manufacturer including labelling, the devices will be returned to the sponsor for analysis.  
The Sponsor-Investigator will contact the Swiss representative of Asensus Surgical and send him 
directly the photo, description of the dysfunction and the dysfunctional device. 
 
 
 
 

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9. CLINICAL INVESTIGATION ASSESSMENTS  
9.1 Clinical investigation flow chart(s) / table of clinical investigation 
procedures and assessments 
 
 
9.2 Assessments of outcomes  
See Chapter 5 
9.2.1 
Assessment of primary outcome  
Intraoperative complications such as bleeding, organ lesion, and procedure interruption will be 
monitored during the operation and reported postoperatively in the CRF 
Postoperative complications and re-operation will be reported at discharge and at the 30-days follow up 
control the CRF.  
Complications will be classified according to its gravity by the Clavien-Dindo classification and by its 
type (postoperative bleeding, anastomotic or staple line leakage, surgical site infection, cardiovascular 
complication, respiratory complications, thromboembolic complication, renal complication...). 
30-day postoperative mortality (= Clavien Dindo grade V) will be reported at discharge and at the 
planned 30-day-checkup in the CRF. 
 
Significant bleeding is defined as a drop in haemoglobin level > 3 g/dl post-operatively compared with 

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the post-operative baseline level and/or any post-operative transfusion of packed red blood cells for a 
falling haemoglobin and/or the need for radiological intervention (such as embolization) and/or re-
operation to stop bleeding [20]. 
Any injury to other intraabdominal organ is either documented in the intraoperative CRF sheet filled by 
the primary surgeon if realized intraoperatively or documented in the electronic CRF if realized 
postoperatively and confirmed by imaging (CT) or during a re-operation or a gastroscopy.  
Anastomotic or stapple leakage is define as a discharge of gastric or intestinal fluid or air from the bowel 
or stomach into the abdominal cavity and is diagnosed by imaging (CT) or during a re-operation or a 
gastroscopy. 
SSI are defined by the United States Centers for Disease Control and Prevention (CDC) as “an infection 
that occurs after surgery in the part of the body where the surgery took place”[21]. Superficial SSI involve 
only the skin and subcutaneous tissue, deep SSI affect tissues under the skin like muscle, fascia, and 
adjacent organs/space SSI affect organs/space opened or manipulated during the operation or foreign 
body [21, 22]. 
Pneumonia is diagnosed by the prevalence of an infiltrate on imaging (either conventional radiography 
or CT-scan) in a patient with a clinically compatible syndrome (eg, fever, dyspnea, cough, and sputum 
production). 
 
9.2.2 
Assessment of secondary outcomes 
Docking time and operation time, as well as conversion rate (into laparoscopic or open surgery), will be 
reported after the operation in the CRF.  
The length of hospital stay will be reported at the discharge of the patient in the CRF and include the 
day of admission to the hospital and including the day of discharge from the hospital. Re-admission rate 
will be reported at the 30-days follow-up. 
 
9.2.3 
Assessment of other outcomes of interest 
See Chapter 5.2 
9.2.4 
Assessment of safety outcomes 
See Chapter 5.1 
9.2.4.1 
Adverse events  
Any adverse event during the operation or until 30 days after the operation will be reported with its time 
of onset, duration, resolution, action to be taken, assessment of intensity, and relationship with the 
medical device. After the operation and during its hospital stay, each patient will be visited at least one 
time a day from the surgical resident. Vital signs, laboratory parameters, and clinical evaluation will help 
us to identify adverse events and treat them appropriately. During the postoperative control at 30 days 
postoperative, the surgeon will perform an anamnesis and clinical evaluation of the patient to identify 
adverse events. If required, further examination such as laboratory parameters, vital signs measurement, 
or diagnostic (CT-Scan, Gastroscopy, Reoperation) may be requested by the surgeon. Laboratory 
measurement will be performed by the laboratory of the Inselspital.  
The most common complications after bariatric surgery are: anastomotic or staple line leakage, 
postoperative bleeding, pulmonary complications, thromboembolic complications and surgical site 
infection. 
 
9.2.4.2 
Laboratory parameters 
A pregnancy test (urine sample) will be performed on the day of the operation upon arrival at the hospital  
(see Chapter 9.3.2). 
At days 1 and 2, after the operation, a blood sample is performed to measure the blood count, CRP, 
kidney value, sodium, and potassium.  
More tests are effectuated according to the clinic of the participant. 
These blood tests correspond to the standard performed in laparoscopic bariatric surgery and no 
additional blood tests are planned in robotic bariatric surgery. 

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9.2.4.3 
Vital signs 
Vital signs will be taken when the participant arrives in its room on the day of the operation. During the 
induction phase, the operation and the waking phase, the participant is monitored (ECG, Blood pressure, 
oxygen saturation, heart rate) under the surveillance of an anaesthesiologist and a nurse anesthetist. 
When the participant is stable, he will be transferred to the regular station. Vital signs will be measure 
three times a day until its release from the hospital. If indicated, vital signs will be measured during the 
postoperative consultation at 30 days. 
This surveillance correspond to the standard performed in laparoscopic bariatric surgery and no 
additional surveillance are planned in robotic bariatric surgery. 
 
9.2.5 
Assessments in subjects who prematurely stop the clinical investigation 
If the bariatric operation was already performed, the follow-up would be performed as usually done in 
our bariatric center (with clinical control at 1, 3, 6, and 12 months during the first year, then each 6 to 12 
months during the following years). The clinicopathological data and outcome will be collected for safety 
reasons but will not be included in the study. 
If the bariatric operation has not yet been performed, but the patient still wants to benefit from the 
bariatric procedure, and if there is no contraindication, this one will be performed with the usual 
laparoscopic technic and the follow-up will be performed as usually done in our bariatric center. The 
clinical data collected will be used for the study up to the point of withdrawal only. 
If the bariatric operation has not yet been performed and the patient does not wish to benefit from it or 
if the procedure is contraindicated, he will be redirected to a conservative weight loss program according 
to the situation. The clinical data collected will be used for the study up to the point of withdrawal only. 
The number of patients who prematurely stop the study will be reported. 
 
9.2.6 
Follow-up of the subjects after the regular termination of the clinical investigation 
As in laparoscopic bariatric surgery, patients are checked after the 3-month follow-up, in a standard way 
at 3, 6, 12 and 18 months after the operation and then annually with a blood test and a clinical check-
up. This follow-up will be done in a similar way for patients who have had robotic bariatric surgery. 
9.3 Procedures at each visit 
9.3.1 
Peroperative consultation 
All patients where bariatric surgery is indicated and desired are seen at this consultation to plan the 
operation. During this visit, and for those who meet the inclusion criteria, the possibility of participating 
in the study will be discussed. The patient will receive oral and written information about the study. If the 
patient meets the inclusion criteria for the study and is willing to participate, he will be included.  
The operation will be planned and explained to the patient. A consultation with the anesthesiologist will 
be organized. 
9.3.2 
Operation and Hospital stay 3-4 days 
 
Day 0:  
 
Pregnancy test (urine) 
 
Exclusion and Inclusion criteria will be tested 
 
Operation  
Hospital stay of 3-4 days.  
After the operation and during its hospital stay, each patient will be visited at least once a day from the 
surgical resident. Vital signs, laboratory parameters, and clinical evaluation will help us to identify 
adverse events and treat them appropriately. If required, further examination such as laboratory 
parameters, vital sign measurements, or diagnostic (CT-Scan, Gastroscopy, Reoperation) may be 
requested by the surgeon.  
9.3.3 
Postoperative consultation (30 day after the operation) 
During the postoperative control at 30 days postoperative, the surgeon performs an anamnesis and 

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clinical evaluation of the patient to identify adverse events. If required, further examination such as 
laboratory parameters, vital sign measurements, or diagnostic (CT-Scan, Gastroscopy, Reoperation) 
may be requested by the surgeon.  
 

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10. SAFETY  
10.1 Definition and Assessment of (Serious) Adverse Events and other safety 
related events 
 
Adverse Event (AE) (Art. 2 Abs 57 MDR) 
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including 
an abnormal laboratory finding) in subjects, users or other persons whether or not related to the MD. 
 
Serious Adverse Event (SAE) (Art. 2 Abs 58 MDR) 
Any adverse event that led to any of the following: 
(a) death, 
(b) serious deterioration in the health of the subject that resulted in any of the following: 
(i)  life-threatening illness or injury, 
(ii) permanent impairment of a body structure or a body function, 
(iii)  hospitalisation or prolongation of patient hospitalisation, 
(iv)  medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function, 
(v)  chronic disease, 
(c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect. 
Note: planned hospitalization for pre-existing condition, or a procedure required by the CIP, without a 
serious deterioration of the health status of the subject, is not considered an SAE 
 
Device deficiency (Art. 2 Abs 59 MDR) 
Inadequacy of a medical device related to its identity, quality, durability, reliability, safety or performance, 
of an investigational device, including malfunction, user errors and inadequate information supplied by 
the manufacturer. 
 
Malfunction (ISO14155) 
Failure of an investigational device to perform in accordance with its intended purpose when used in 
accordance with the instructions for use or the CIP. 
 
Device deficiency with Serious Adverse Device Effect (SADE) potential (Art. 80 Abs 1 letter c MDR; 
ISO14155) 
Any device deficiency that might have led to a serious adverse event if appropriate action had not been 
taken, intervention had not occurred, or circumstances had been less fortunate. 
 
Adverse Device Effect (ADE) (ISO14155) 
Adverse event possibly, probably or causally related to the use of an investigational device or 
procedures.  
 
Serious Adverse Device Effect (SADE) (ISO14155) 
Adverse device effect (ADE) that has resulted in any of the consequences characteristic of a serious 
adverse event. 
 
Unanticipated Serious Adverse Device Effect (USADE) (ISO14155) 
Serious adverse device effect (SADE) which by its nature, incidence, severity or outcome has not been 
identified in the current version of the risk analysis report. 
 
Causal Relationship of SAE (MDCG 2020-10/1) 
A causal relationship towards the medical device or the procedure of the investigation should be rated 

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by the Co-Investigators and the Sponsor-Investigator as follows: 
 
Not related: The relationship to the device or procedures can be excluded. 
 
Possible: The relationship with the use of the investigational device is weak but cannot be ruled 
out completely. Alternative causes are also possible. 
 
Probable: The relationship with the use of the investigational device seems relevant and/or the 
event cannot reasonably be explained by another cause. 
 
Causal relationship: The serious event is associated with the investigational device or with 
procedures beyond reasonable doubt. 
 
10.2 Adverse events categorization 
 
The adverse events are categorized by the PI and the Sponsor using the following algorithm:   
 
Does the AE meet the seriousness criteria? 
o 
No, it is not serious 
 
Is the relationship to the device or the procedure possible, probable or causal? 
 
No: non-related AE 
 
Yes: ADE 
o 
Yes, it is serious: SAE 
 
Is the relationship to the device or the procedure possible, probable or causal? 
 
No: non-related SAE 
 
Yes: SADE 
o 
Is it anticipated (within expected type, severity and frequency of the complications)? 
 
No: unanticipated SADE (USADE) 
 
Yes: anticipated SADE (ASADE) 
 
10.3 Documentation and reporting in Medical Device Category C clinical 
investigations 
Not applicable  
 
10.4 Documentation and reporting in Medical Device Category A clinical 
investigations 
Device deficiencies (DD) and all adverse events (AE) including all serious adverse events (SAE) are 
collected, fully investigated and documented in the source document and appropriate case report form 
(CRF) during the entire investigation period, i.e. from patient’s informed consent until the last CIP-
specific procedure, including a safety follow-up period. 
 Documentation of AEs (including SAEs) by the Co-Investigators includes diagnosis or symptoms, 
start and stop dates of event, event treatment, event resolution, assessment of seriousness and 
causal relationship to MD and/or investigation procedure (Art. 32 ClinO-MD, ISO14155). 
 Documentation of DDs by the Co-Investigator includes description of event, start date, 
investigational device information, action taken with regard to the investigational device, and 
whether the DD led to an AE. The Sponsor-Investigator shall review all DDs and determine and 
document in writing whether they could have led to a SAE (DD with SADE potential) (Art 32. ClinO-
MD, ISO14155). 
Information on AEs is systematically collected during the hospitalization after the operation (2-3 days) 
and at the regular study visits 30-days after to the procedure, as applicable and clinically justified in the 
context of the specific protocol. In case of premature study withdrawal of a participant after the operation, 
he will still benefit of a 30-days visit as it is the case for all patients after bariatric surgery in our center. 
10.4.1 Foreseeable adverse events and anticipated adverse device effects 
Possible adverse effects specific to the SenhanceTM Surgical System are the same as traditional 
laparoscopic surgery. Due to a learning curve, the operation time will probably be, in the beginning, 

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longer than in general laparoscopic bariatric surgery.  
Mortality at less than 30 days after a Sleeve Gastrectomy is estimated at 0.29% (95% CI : 0.11 to 0.63%) 
and for Roux-en-Y gastric bypass at 0.38% (95% CI: 0.22-0.59%). The reoperation rate after a Sleeve 
Gastrectomy is estimated at 2.96% and for Roux-en-Y gastric bypass at 5.34%. The postoperative 
complication rate after a Sleeve Gastrectomy is estimated at 8.9% and for Roux-en-Y gastric bypass at 
12.0%. [23] 
 
The most common complications after bariatric surgery and their treatments are:  
- 
anastomotic or staple line leakage  endoscopic or surgical closure / drainage 
- 
postoperative bleeding  blood transfusion, coagulation optimization, reoperation 
- 
pulmonary complications  antibiotics, invasive ventilation 
- 
thromboembolic complications  anticoagulation 
- 
surgical site infection  local treatment, VAC therapy, antibiotics 
 
We expect no adverse events specifically related to SenhanceTM Surgical system. Expected possible 
adverse events are the same as in traditional laparoscopic bariatric surgery. For other robotic 
platforms, literature reports a similar rate of postoperative morbidity and mortality between robotic and 
laparoscopic bariatric surgery [9, 24].  
 
10.4.2 Reporting of Safety related events 
Reporting to the Sponsor: 
All SAEs, device deficiencies and health hazards that require measures are reported to the Sponsor-
Investigator by the Co-Investigators (or authorized designee) within 24 hours after becoming aware of 
the event. Device deficiencies are assessed regarding their potential to lead to an SAE. DD are 
assessed regarding their potential to lead to an SAE. 
Pregnancies  
On the day of the operation each female participant that can be pregnant (except hysterectomy, 
postmenopausal) will have a pregnancy test. If the test is positive, the operation will be reported and 
the participant excluded from the study.  
Reporting of pregnancies after the operation is not necessary.  
 
Reporting to the Competent Ethics Committee: 
The Sponsor-Investigator reports to the CEC promptly any serious adverse event which has a causal 
relation with the MD, comparator or procedure/test method or where a causal relation appears to be 
possible (Art. 33 ClinO-MD). 
In order to ensure prompt notification, the Sponsor-Investigator may initially submit an incomplete 
notification.  
If safety and health hazards that require measures must be taken immediately during the conduct of the 
investigation, the Sponsor notifies the CEC within 2 days of these measures and the circumstances 
which made them necessary (Art. 34 ClinO-MD). 
 
Periodic safety reporting (Art. 35 ClinO-MD): 
An Annual Safety Report (ASR) is submitted by the Sponsor-Investigator to the CEC, yearly. The ASR 
contains a list of all SADEs and DDs and a report on their degree of seriousness, causal relationship 
with the MD and procedure and on subjects’ safety. 
 
Other reporting is done according to provisions of MD vigilance as per Art. 87-90 MDR (Art. 33 abs 4.b 
ClinO-MD) and Art. 67 MedDO.  
 
 

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10.5 Assessment, notification and reporting on the use of radiation sources 
Not applicable 
 
 

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11. STATISTICAL METHODS  
11.1 Hypothesis 
The investigator’s hypothesis is that, robotic in bariatric is a safe and efficient way to perform bariatric 
surgery. 
11.2 Determination of Sample Size  
The study is designed as single arm, two-stage phase II study with a stopping rule for safety using the 
Simon’s two-stage design. 
Literature shows a complication rate for conventional laparoscopic bariatric surgery of 10%. We expect 
to have similar complication rates with bariatric surgery. For calculation of the safety stopping point we 
set the maximum acceptable threshold of complications at 25%.  
We used Simon’s 2 stage design to derive the time point of an interim analysis and a stopping rule for 
safety, assuming Type I error to be 0.05 and Type II error 0.8. 
Simon’s optimal two-stage design yielded the following numbers with respect to a 25% threshold: 
 Interim analysis will be done at 22 patients. If there are 5 or more events, the study will stop fo
r safety. 
 Final analysis will be done at 39 patients. Robotic surgery can be regarded as successful if les
s than 6 events occurred. 
 
11.3 Statistical criteria of termination of the investigation  
See 11.2 
 
11.4 Planned Analyses  
11.4.1 Datasets to be analysed, analysis populations 
In the absence of contraindication (see exclusion criteria below) we will include consecutive patients 
which are eligible for bariatric surgery according to the SMOB-Criteria and having a robotic bariatric 
operation (including Sleeve gastrectomy, Y-Roux gastric bypass, Omega-loop gastric bypass) at our 
Adiposity Center at the Inselspital, University Hospital Bern, Switzerland. 
11.4.2 Primary Analysis 
In this pilot trial, feasibility and safety of the robotic platform in bariatric surgery will be assessed. 
For the primary outcome (safety), following variable will be reported: intraoperative complications, 
postoperative morbidity, and postoperative mortality. 
For the secondary outcomes (feasibility) following variable will be analysed: Docking time, Operation 
time, conversion rate, length of hospital stay and rehospitalisation rate.  
Baseline characteristics and perioperative data will be presented as medians (IQ-range) for continuous 
variables or frequencies (percentages) for categorical variables. 
Operation and docking time will be represented as a visual graphic with its evolution over time. 
Descriptive statistics, graphs will be performed with SPSS Version 25.  
For the primary outcome (safety), the analysis will be done after the 30-day follow-up of the last 
participant.  
For the secondary outcome (feasibility), the analysis will be done after the 30-day follow-up of the last 
participant.  
 
11.4.3 Secondary Analyses 
Not applicable 

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11.4.4 Interim analyses 
To guarantee the procedure's safety, the intraoperative and postoperative complications, as well as the 
postoperative mortality, will be analyzed after inclusion of 22 participant and will be presented as 
frequencies (percentages). The analysis will be done by the Sponsor-Investigator. If there are 5 or more 
events, the Sponsor-Investigator will terminate the study for safety. 
11.4.5 Deviation(s) from the original statistical plan  
No deviation is planned.  
 
11.5 Handling of missing data and drop-outs  
There will be no imputation for missing values. Missing values are reported and only available data are 
used for descriptive analysis.  
Drop-outs will not be replaced.  
 
 
 

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12. QUALITY ASSURANCE AND CONTROL  
The Sponsor-Investigator is responsible for implementing and maintaining quality assurance and 
quality control systems with written SOPs and Working Instructions. The co-investigators are 
responsible for proper training of all involved study personnel. 
12.1 Data handling and record keeping / archiving  
 
12.1.1 Case Report Forms  
Data are recorded on paper by the primary surgeon conducting the procedure after the operation, by 
the attending surgical resident releasing the patient at the end of the hospital stay and by the surgeon 
performing the bariatric consultation prior to the operation during the enrollment of the participant and 
at 30 days postoperative. The paper CRF’s are provided with the name of the Sponsor-Investigator or 
the co-investigators and their signature. These data will be scanned in an electronic Case Report 
Forms (p-/e-CRF). For each enrolled study participant, a CRF is maintained. CRFs will be kept current 
to reflect the subject status at each phase during the course of study. Participants will be coded in the 
CRF with a code identification (participant number in combination with the year of birth). The 
information on the paper CRF’s is entered into an electronic database anonymously by the Co-
Investigator.  
12.1.2 Specification of source data and source documents  
Source data are available at the site to document the existence of the study participants. Source data 
include the original documents relating to the study, as well as the medical treatment and medical history 
of the participant. The last one is found in the hospital information system (IPDOS). 
The source documents in the study are: 
-      Eligibility form CRF  
-      Intra-operative CRF 
-      Post-operative CRF 
-      30-day control CRF 
-      SAEs, AEs 
Paper data will be kept under lock in the study nurses' offices at the Inselspital. 
Electronic data will be stored on the Inselspital's Sharepoint server and protected by a password.  
Access to the data is restricted to the persons involved in the study. No other persons have access to 
the data, and no data is passed on to others. 
 
12.1.3 Archiving of essential clinical investigation documents 
All study data must be archived for a minimum of 10 years after study termination or premature 
termination of the clinical trial. 
Paper data will be kept under lock in the study nurses' offices at the Inselspital. 
Electronic data will be stored on the Inselspital's Sharepoint server and protected by a password.  
 
12.2 Data management  
12.2.1 Data Management System  
Data are extracted from the hospital information system (ipdos) and from the paper CRF’s by the co- 
investigator (Pauline Aeschbacher) and entered in an Excel sheet. The Excel document is stored on a 
SharePoint platform that was centrally set up by the Inselspital. It fulfills all requirements of the Human 
Research Act (HRA). The physical location of the servers is in Zollikofen BE. Sharepoint stores the 
following versions of the document allowing for tracking changes. The Sharepoint database is 
accessible only by the Sponsor-Investigator and the co-investigators. 
All identifying data (only PID and FID) will be kept separate from the actual study data. All digital 
documents are password protected. No identifying paper data will be made. 

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12.2.2 Data security, access and back-up  
Unencrypted data is only viewed by the Sponsor-Investigator and the co-investigators.  
Project data will be handled with uttermost discretion and is only accessible to authorized personnel 
who require the data to fulfil their duties within the scope of the research project. On the CRFs and other 
project specific documents, participants are only identified by a unique participant number. 
Study-related data of the patient will be collected in a coded manner.   
The SharePoint server is kept in a locked server-room. Only the system administrators have direct 
access to the server and back-up tapes. Each access on the platform occurs only with personal 
credentials (user name and password). The credentials are managed centrally in the Active Directory 
System of the Inselspital. An anonymous access to the SharePoint platform is not possible. A role 
concept (read, read/write and administrator) is realized using SharePoint groups and regulates 
permission for each user and each research project in order to use the system as he/she requires. Every 
access to the SharePoint server is recorded by the audit function of the SharePoint Server. This audit 
trail contains information about the accessing user, date and time of access and the name of the 
document that was accessed. The tracking of the actual data changes are not included in this audit trail. 
Therefore, the SharePoint versioning functionality is at all times switched on. The backup of the server 
and the database instances is done once a week by 1 full and 6 incremental backups. The retention 
time is 30 days. 
In case of withdraw the data and samples collected up to that point will still be evaluated in encrypted 
form. The key allocation will be then destroyed so that the data remain anonym.  
12.2.3 Analysis and archiving 
At final analyses data files will be extracted from the SharePoint platform into statistical packages to be 
analyzed.  
Coded data are stored digitally on a password protected SharePoint-database on the Insel-server for 
ten years.   
The key document to decode data is stored separately in a specific folder on the Insel-server protected 
by a password with access by our study nurses only (for ten years). Our study nurses are not 
participating in the study and, therefore, capable of storing the key document (HFG Art. 26.) 
 
12.2.4 Electronic and central data validation  
Data are validated by visual control using graphs to detect possible misentries.  
 
12.3 Monitoring  
In order to guarantee a high study quality and data retrieval, on-site monitoring will be performed by a 
Studynurse from the Inselspital not participating in the study. Regular monitoring visits at the 
Inselspital will take place prior to the start and during the interim analysis and are organised by the 
Sponsor-Investigator.  
Following documents will be monitored: informed consents and informed consent process, source 
data verification, inclusion and exclusion criteria, processing of subjects’ data, preservation of 
subject’s confidentiality.  
2 visits will take place during the study (one before the beginning of the study, one during the interim 
analysis). 
 
12.4 The source data/documents are accessible to monitors and questions are 
answered during monitoring by the Sponsor Investigator and the site 
staff.Audits and Inspections  
There are no planned procedures for auditing trial conduct other than the internal inspection and control 
of the principal investigator. 
However, the study documentation and the source data and documents are accessible to the CEC, and 
questions are answered during every surprise inspection. Of course, all involved parties must keep the 

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participant data strictly confidential. 
12.5 Confidentiality, Data Protection  
Direct access to source documents will be permitted for purposes of inspections and monitoring (12.4) 
(ICHE6, 6.10). 
During and after the study the Investigators as well as the people involved in the publication and 
dissemination of the study related paper will have access to protocol, dataset and statistical code. 
12.6 Storage of biological material and related health data  
See 12.2.3  
 

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13. PUBLICATION AND DISSEMINATION POLICY  
The results of the study will be published via oral communications during national and international 
meetings and via a written publication. The principal investigator will provide the Ethics Committee with 
a summary of the study's findings. The publication of the study results will be authored by Pauline 
Aeschbacher. The senior author will be Philipp Nett. Co-authorship on any of the publications will be 
based on a conceptual contribution to the study according to the criteria of the International Committee 
of Medical Journal Editors. 
 
 
 

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14. FUNDING AND SUPPORT  
14.1 Funding  
There is no funding for this study. 
 
14.2 Other Support  
Not applicable 
15. INSURANCE  
Not applicable (The category A study entails only minimal risk.) 
 

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16. REFERENCES  
1. 
Reoch, J., et al., Safety of laparoscopic vs open bariatric surgery: a systematic review and meta-
analysis. Arch Surg, 2011. 146(11): p. 1314-22. 
2. 
Clapp, B., et al., Conversions to open surgery greatly increase complications: an analysis of the 
MBSAQIP database. Surg Obes Relat Dis, 2020. 16(5): p. 634-643. 
3. 
Iranmanesh, P., et al., Robotic Primary and Revisional Bariatric Surgery. Surg Clin North Am, 
2020. 100(2): p. 417-430. 
4. 
Hislop, J., et al., Muscle activation during traditional laparoscopic surgery compared with robot-
assisted laparoscopic surgery: a meta-analysis. Surg Endosc, 2020. 34(1): p. 31-38. 
5. 
Spinelli, A., et al., First experience in colorectal surgery with a new robotic platform with haptic 
feedback. Colorectal Dis, 2017. 
6. 
Hutchins, A.R., et al., Objective Assessment of the Early Stages of the Learning Curve for the 
Senhance Surgical Robotic System. J Surg Educ, 2019. 76(1): p. 201-214. 
7. 
Magouliotis, D.E., et al., Robotic versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity: 
a Systematic Review and Meta-analysis. Obes Surg, 2017. 27(1): p. 245-253. 
8. 
Kostakis, I.D., et al., Comparison Between Robotic and Laparoscopic or Open Anastomoses: A 
Systematic Review and Meta-Analysis. Robot Surg, 2019. 6: p. 27-40. 
9. 
Aiolfi, A., et al., Roux-en-Y gastric bypass: systematic review and Bayesian network meta-
analysis comparing open, laparoscopic, and robotic approach. Surg Obes Relat Dis, 2019. 
15(6): p. 985-994. 
10. 
Li, K., et al., Robotic Versus Laparoscopic Bariatric Surgery: a Systematic Review and Meta-
Analysis. Obes Surg, 2016. 26(12): p. 3031-3044. 
11. 
Darwich, I., et al., A roadmap for robotic-assisted sigmoid resection in diverticular disease using 
a Senhance Surgical Robotic System: results and technical aspects. J Robot Surg, 2020. 14(2): 
p. 297-304. 
12. 
Rumolo, V., et al., Senhance robotic platform for gynecologic surgery: a review of literature. 
Updates Surg, 2019. 71(3): p. 419-427. 
13. 
Kastelan, Z., et al., Extraperitoneal radical prostatectomy with the Senhance Surgical System 
robotic platform. Croat Med J, 2019. 60(6): p. 556-559. 
14. 
Schmitz, R., et al., Robotic Inguinal Hernia Repair (TAPP) First Experience with the New 
Senhance Robotic System. Surg Technol Int, 2019. 34: p. 243-249. 
15. 
Melling, N., et al., Robotic cholecystectomy: first experience with the new Senhance robotic 
system. J Robot Surg, 2019. 13(3): p. 495-500. 
16. 
Schmitz, R., et al., Robotic-Assisted Nissen Fundoplication with the Senhance(R) Surgical 
System: Technical Aspects and Early Results. Surg Technol Int, 2019. 35: p. 113-119. 
17. 
Samalavicius, N.E., et al., Robotic surgery using Senhance((R)) robotic platform: single center 
experience with first 100 cases. J Robot Surg, 2020. 14(2): p. 371-376. 
18. 
Stephan, D., H. Salzer, and F. Willeke, First Experiences with the New Senhance(R) Telerobotic 
System in Visceral Surgery. Visc Med, 2018. 34(1): p. 31-36. 
19. 
Gueli Alletti, S., et al., The Senhance surgical robotic system ("Senhance") for total 
hysterectomy in obese patients: a pilot study. J Robot Surg, 2018. 12(2): p. 229-234. 
20. 
Rahbari, N.N., et al., Post-hepatectomy haemorrhage: a definition and grading by the 
International Study Group of Liver Surgery (ISGLS). HPB (Oxford), 2011. 13(8): p. 528-35. 
21. 
United States Centers for Disease Control and Prevention. https://www.cdc.gov/HAI/ssi/ssi.html. 
22. 
European Centre for Disease Prevention and Control. Surveillance of surgical site infections in 
Europe 2010–2011. Stockholm: ECDC; 2013. 
23. 
Bray, G.A., et al., Management of obesity. Lancet, 2016. 387(10031): p. 1947-56. 
24. 
Wang, L., et al., Robotic Versus Laparoscopic Roux-en-Y Gastric Bypass for Morbid Obesity: a 
Systematic Review and Meta-Analysis. Obes Surg, 2018. 28(11): p. 3691-3700. 
 

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17. APPENDICES 
1. Medical Devices: CE Certificate 
 
2. Medical Devices: List of norms (vollständig eingehaltene, teilweise eingehaltene) 
 
3. Patient Information and informed consent, General consent