Safety and Performance of the Motorized Spiral Endoscope (PowerSpiral) in Subjects Indicated for Small-bowel Enteroscopy: A PMCF Registry
Conditions: Small Bowel Disease
Sponsor: Olympus Europe SE & Co. KG

Clinical Investigation Plan Template 
 
Confidential 
DOC-18-00244 Rev. 1 
 
 
Printed Versions are uncontrolled and may be outdated. They are for information only.  
CLINICAL INVESTIGATION PLAN 
Safety and Performance of the 
Motorized Spiral Endoscope 
(PowerSpiral) in Subjects indicated 
for small-bowel enteroscopy:  
A PMCF Registry 
SAfety and Performance of the MotorIzed Spiral 
Endoscope - The SAMISEN study 
 
 
Sponsor:  
Olympus Europa SE & Co. KG 
Investigational Device: 
Motorized Spiral Endoscope (PowerSpiral) INTESTINAL 
VIDEOSCOPE OLYMPUS PSF-1 in combination with SINGLE 
USE POWERSPIRAL TUBE DPST-1 used with the motor control 
unit POWERSPIRAL CONTROL UNIT PSCU. 
CIP Reference No.: 
2018-GI (OEKG) – 01 
Document Version: 
Final Version 02 
Elaboration Date: 
 23. April 2019 
Amendments: 
01 

Clinical Investigation Plan Template 
 
Confidential 
DOC-18-00244 Rev. 1 
 
 
Printed Versions are uncontrolled and may be outdated. They are for information only.  
 
THE STUDY WILL BE CONDUCTED IN COMPLIANCE WITH THE DECLARATION 
OF HELSINKI, GOOD CLINICAL PRACTICE (GCP), DIN (EN) ISO 14155:2011, 
AND ALL APPLICABLE NATIONAL LAWS AND REGULATIONS. 
 
Confidential Information 
This clinical investigation plan is the confidential information of Olympus Europa SE & Co. KG 
and is intended solely for guidance of the clinical investigation. This investigation plan may not be 
disclosed to parties not associated with this clinical investigation or used for any purpose without 
the prior written consent of Olympus Europa SE & Co. KG. 
 
 

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DECLARATION OF PRINCIPAL INVESTIGATOR 
I have read this clinical investigation plan (CIP) and agree that it contains all the information 
required to conduct the trial. I agree to conduct the trial as set out in this CIP. I will not enroll the 
first subject in the trial until I have received approval for conduct of this study from the appropriate 
ethics committee and until all legal requirements have been fulfilled. I agree to obtain in the 
manner described in the CIP a written informed consent to participate from all subjects enrolled in 
this study and to keep the dated and signed consent forms for 15 years.  
 
Site number: 
< Enter Site number here> 
 
Principal Investigator: 
< Enter name of PI here> 
 
______________________________ 
_____________________________________ 
Place, Date 
Signature Investigator 

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TABLE OF CONTENTS 
 
Signature Page ........................................................................................................................................ 3 
Declaration of Principal Investigator ........................................................................................................ 5 
Contact Addresses and Responsibilities ................................................................................................. 6 
Table of Contents .................................................................................................................................... 7 
List of abbreviations and definitions ...................................................................................................... 11 
Trial Summary ....................................................................................................................................... 12 
1 
Background and Rationale ........................................................................................................... 15 
1.1 
Description of the Investigational Device ................................................................................. 15 
1.2 
Justification for the Design of the Clinical Investigation ........................................................... 16 
1.3 
Risks and Benefits .................................................................................................................... 17 
2 
Trial Objectives ............................................................................................................................. 19 
2.1 
Objective ................................................................................................................................... 19 
3 
Design of the Clinical Investigation ............................................................................................... 20 
3.1 
General ..................................................................................................................................... 20 
3.1.1 
Design Overview .................................................................................................................. 20 
3.1.2 
Randomization and Blinding or Assignment of Investigational Device ................................ 20 
3.1.3 
Variables in the Clinical Investigation .................................................................................. 20 
3.1.4 
Replacement of Subjects ..................................................................................................... 21 
3.2 
Investigational Device(s) and Comparators ............................................................................. 21 
3.2.1 
Investigational Device(s) ...................................................................................................... 21 
3.2.2 
Comparator Devices(s) ........................................................................................................ 21 
3.2.3 
Reference Device(s) ............................................................................................................ 21 
3.2.4 
Other Medical Device / Medication ...................................................................................... 21 
3.3 
Subjects .................................................................................................................................... 21 
3.3.1 
Inclusion criteria ................................................................................................................... 21 
3.3.2 
Exclusion criteria .................................................................................................................. 22 
3.3.3 
Subject Withdrawal or discontinuation ................................................................................. 22 
3.3.4 
Point of Enrolment ................................................................................................................ 23 
3.3.5 
Duration of the Clinical Investigation .................................................................................... 23 

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3.3.6 
Sample size .......................................................................................................................... 23 
3.4 
Procedures ............................................................................................................................... 25 
3.4.1 
Overview of the Procedures and Laboratory Measurements .............................................. 25 
3.4.2 
Description of clinical investigation related procedures and assessed data ........................ 25 
3.4.3 
Study Visits Schedule .......................................................................................................... 29 
3.4.4 
Concomitant treatments ....................................................................................................... 29 
3.4.5 
Medical Care after Termination of the Clinical Investigation ................................................ 30 
3.4.6 
Deviations from medical standard ........................................................................................ 30 
3.5 
Monitoring Plan ......................................................................................................................... 30 
3.5.1 
Responsibilities .................................................................................................................... 30 
3.5.2 
Source Data Definition and Verification (SDV) .................................................................... 30 
4 
Statisticis ....................................................................................................................................... 32 
4.1 
Statistical methods ................................................................................................................... 32 
4.1.1 
Background and demographic characteristics ..................................................................... 32 
4.1.2 
Efficacy evaluation ............................................................................................................... 32 
4.1.3 
Safety evaluation .................................................................................................................. 33 
4.1.4 
Interim analysis .................................................................................................................... 33 
4.1.5 
Other evaluations ................................................................................................................. 33 
4.2 
Subgroup Analyses .................................................................................................................. 33 
4.3 
Missing/spurious Data .............................................................................................................. 33 
5 
Data Management ........................................................................................................................ 34 
5.1 
Data recording .......................................................................................................................... 34 
5.2 
Data processing ........................................................................................................................ 34 
6 
Amendments to the CIP ................................................................................................................ 35 
3.3.1 Inclusion criteria ....................................................................................................................... 38 
7 
CIP Deviations .............................................................................................................................. 41 
8 
Device Accountability .................................................................................................................... 42 
9 
Statement of Compliance ............................................................................................................. 43 
9.1 
Ethical and Regulatory Aspects ............................................................................................... 43 
9.2 
Patient Coverage ...................................................................................................................... 43 

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9.3 
Retention of Documents ........................................................................................................... 43 
9.4 
Auditing procedures .................................................................................................................. 44 
10 
Informed Consent ......................................................................................................................... 45 
11 
Adverse Events, Adverse Device Effects and DevIce Deficiencies ............................................. 46 
11.1 
Definitions (according to ISO 14155:2011) .............................................................................. 46 
11.1.1 
Adverse event (AE) .......................................................................................................... 46 
11.1.2 
Adverse Device Effect (ADE) ........................................................................................... 46 
11.1.3 
Serious Adverse Event / Serious Adverse Device Effect (SAE /SADE) .......................... 47 
11.1.4 
Device Deficiencies.......................................................................................................... 48 
11.2 
Documentation ......................................................................................................................... 48 
11.2.1 
(Serious) Adverse Events / Adverse Device Effects ........................................................ 48 
11.2.2 
Device deficiencies .......................................................................................................... 48 
11.3 
Reporting Responsibilities ........................................................................................................ 48 
11.3.1 
Serious Adverse Events (SAE) / Serious Adverse Device Effects (SADE) ..................... 48 
11.3.2 
Device deficiencies .......................................................................................................... 49 
11.3.3 
Responsible Nominated Safety Contact .......................................................................... 49 
11.4 
Anticipated Adverse Events...................................................................................................... 49 
11.5 
Data Monitoring Committee ...................................................................................................... 50 
12 
Vulnerable Population ................................................................................................................... 51 
13 
Suspension or Premature Termination ......................................................................................... 52 
14 
Publication Policy .......................................................................................................................... 53 
15 
Bibliography .................................................................................................................................. 54 
16 
Study Timeline .............................................................................................................................. 55 
17 
Annex 01: Deep Enteroscopy PROCEDURE ............................................................................... 56 
17.1 
General Information .................................................................................................................. 56 
17.2 
General Insertion tips ............................................................................................................... 56 
17.3 
General Withdrawal tips ........................................................................................................... 56 
17.4 
Antegrade Approach ................................................................................................................. 57 
17.4.1 
Inserting the Scope .......................................................................................................... 57 
17.4.2 
Passing through the Pharynx & Esophagus .................................................................... 58 

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17.4.3 
Passing through the Stomach .......................................................................................... 59 
17.4.4 
Passing through the Duodenum ...................................................................................... 60 
17.4.5 
Passing through the Small Bowel Distal to the Ligament of Treitz .................................. 61 
17.4.6 
Reaching the Terminal Ileum ........................................................................................... 62 
17.4.7 
Withdrawal Techniques ................................................................................................... 63 
17.5 
Retrograde Approach ............................................................................................................... 65 
17.5.1 
Passing through the Colon .............................................................................................. 65 
17.5.2 
Eliminating a Loop ........................................................................................................... 66 
17.5.3 
Passing through the Ileo-cecal Valve .............................................................................. 68 
17.5.4 
Passing through the Small Bowel .................................................................................... 69 
17.5.5 
Reaching the Proximal Jejunum ...................................................................................... 69 
17.5.6 
Withdrawal Techniques ................................................................................................... 70 
 
 
Table of tables 
Table 1 Precision of estimations of the rate of patients with at least one SAE ............................. 24 
Table 2 List of study procedures .................................................................................................... 25 
Table 3 List of changes CIP version 01 versus CIP version 02. .................................................... 35 
Table 4 List of anticipated (Serious) Adverse Events .................................................................... 50 
 

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1 
BACKGROUND AND RATIONALE 
Small bowel enteroscopy is usually performed in order to evaluate gastrointestinal bleeding, small 
bowel tumors, polyps, inflammatory or other small bowel diseases. Video capsule endoscopy, 
single- (SBE), double-balloon (DBE) or spiral enteroscopy are the most popular non-surgical 
endoscopic techniques in this context. Hereof the endoscopic approach offers additional 
diagnostic and therapeutic options as biopsies and direct therapeutic intervention is possible 
compared to capsule endoscopy. These enteroscopy systems – also called overtube-assisted 
enteroscopy (OAE) techniques - are used to visualize the small-bowel and proceed with a 
therapeutic intervention, either during the same or in a subsequent session. For example, the 
DBE utilizes distal and proximal balloons that can be inflated and deflated to “anchor” and move 
the bowel, thereby assisting the operator in advancing the endoscope while gathering the bowel 
onto the overtube shaft. 
However, the SBE and DBE procedures are time consuming and usually require 2 operators to 
perform this kind of examination.  
1.1 
Description of the Investigational Device 
The Motorized Spiral Enteroscope (INTESTINAL VIDEOSCOPE OLYMPUS PSF-1 and SINGLE 
USE POWERSPIRAL TUBE DPST-1) in conjunction with the motor control unit (POWERSPIRAL 
CONTROL UNIT PSCU) now offers a new technology which combines the advantageous options 
of enteroscopy with a faster and less invasive approach. The intended use of this CE-certified 
medical device (PowerSpiral) is to examine the lumen of the small intestine to provide clear 
images for diagnostic and therapeutic purposes in the management and treatment of small-bowel 
disease.  
The system is similar to other currently marketed endoscopes and incorporates a flexible 
insertion tube, light source, digital imaging, and channels for passing accessories for sample 
collection or therapeutic interventions. In contrast to the predecessor a novel user-controlled 
motor rotates a special spiral cuff (SINGLE USE POWERSPIRAL TUBE DPST-1) located on the 
endoscope’s insertion tube (POWERSPIRAL CONTROL UNIT PSCU). Rotation of this cuff, 
which has soft spiral-shaped “fins”, pleats the small bowel on to the endoscope’s insertion tube, 
thereby allowing rapid and atraumatic access into deeper regions of the small bowel. The 
Rotating speed is 30 rpm and the Rotation torque is controlled mechanically until torque limit is 
reached (until a limiting function is activated). 
With this new medical device system deep enteroscopy allows complete visualization of the small 
bowel. The motorized PowerSpiral can be used for either antegrade or retrograde approach 
according to the operator’s preference or individual patient anatomy. The new device shall 

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contribute to easier and faster disease clarification and necessary therapeutic interventions in all 
areas of the small intestine. 
The study investigators shall have considerable experience in deep enteroscopy. The study team 
will undergo special training (arranged by the Sponsor) to become comfortable with all handling 
characteristics of this novel device. The product and procedure training is mandatory prior to 
enrolling the first study subject and will be documented accordingly. 
1.2 
Justification for the Design of the Clinical Investigation 
Deep enteroscopy is well established with Balloon assisted enteroscopy procedures, however 
there is a need for innovative and faster methods, less resource utilization which at the same time 
provide more comfort for the patients. 
Currently available and published data for PowerSpiral was collected by means of Investigator 
Initiated Trials (Mans et al. 2018; Neuhaus et al. 2016; Beyna et al. 2018; Beyna 2018). With this 
Olympus sponsored Registry further data about performance and safety for this new medical 
device will be collected in a larger patient population. Obtained safety data will be compared to 
data published in respective guidelines or literature.  
This study will be performed in parallel to the European market launch of this new medical device. 
It is a registry study with a CE marked medical device whose application within the intended use 
will be captured. The registry and does not impose any additional procedure or risk to the patient 
as we strive to document daily clinical routine. Therefor this study is observational (non-
interventional) in nature.  
For the same reason inclusion criteria are kept as broad as possible. In summary all patients are 
eligible where the physician realizes an indication for deep enteroscopy for further diagnostic or 
therapeutic work up. The exclusion criteria will only affect patients under the age of 18 years and 
pregnant women. Otherwise clinical judgement of the treating physician is the only relevant and 
leading reason for exclusion. Of course giving signed informed consent by all study subjects is a 
prerequisite for participation in this “registry”. 
For this study approximately 12 European sites will be recruited that offer deep enteroscopy to 
their patients. This international multi-center setup will give a more representative picture and 
avoid a single-site bias. Furthermore enrollment will be completed earlier compared to a single 
center approach.   
The prevailing complications of a deep enteroscopy are pancreatitis, perforation, bleeding and 
adverse events associated with sedation or anesthesia (Aktas et al. 2010; Akarsu et al. 2014; 
Akerman and Cantero 2009; Arulanandan et al. 2016; He et al. 2013; Moeschler and Mueller 
2015). Generally these are independent if the procedure was performed as a diagnostic or 
therapeutic procedure however the complications rate is usually higher in interventional cases 
(Rondonotti et al. 2018). 

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The main objective of the SAMISEN study is to assess the performance and safety of diagnostic 
and therapeutic procedures with the newly designed Olympus Motorized Spiral Enteroscope 
(INTESTINAL VIDEOSCOPE OLYMPUS PSF-1 and SINGLE USE POWERSPIRAL TUBE 
DPST-1) system in combination with the motor control unit (POWERSPIRAL CONTROL UNIT 
PSCU). All Serious Adverse Events (SAE) observed in this study will be documented so the 
overall SAE rate as well as the number of individual types of complications (bleeding, pancreatitis 
etc.) can be calculated.  
The very recent publication of Rondonotti (Rondonotti et al. 2018) for device-assisted 
enteroscopy for diagnosis and treatment of small-bowel disorders represents an excellent source 
for comparison. Hence this study is designed as a prospective study without control group. The 
resulting SAE rate will be compared to the historical data from this ESGE Technical Review 
(Rondonotti et al. 2018). 
The performance will be characterized by calculating the Diagnostic and Therapeutic Yield, Total 
Procedure Time, time needed for Therapeutic Intervention, Total Small Bowel Enteroscopy Rate 
and user feedback on device handling.   
1.3 
Risks and Benefits 
All patients present a medical challenge which requires a deep enteroscopy for diagnostic and/or 
therapeutic purpose(s). Independent of the clinical study this kind of examination has certain 
clinical risks associated with such a procedure which must be balanced again other treatment 
alternatives (e.g. open surgery). After careful consideration of risk and benefits the investigator 
decided to proceed with direct visualization of the small bowel and adequate therapeutic 
inventions. Due to the non-interventional character of this study (i.e. registry) no additional 
protocol driven procedure besides medical standard are required. In summary the potential risk a 
subject enrolled into the SAMISEN study is considered identical to the risks he/she would be 
facing without participating in this study. 
The complication rate associated with endoscopic procedures is usually low. Experience with 
deep enteroscopy of the small-bowel has been published for SBE and DBE. Distribution and 
incidence of complications depend whether it was a diagnostic or therapeutic approach. For 
therapeutic procedures tissue usually is removed or biopsies obtained which carries a higher 
complication rate compared to purely diagnostic procedures. A deep enteroscopy examination is 
performed with sedation or anesthesia, depending on the hospital standards. Any anesthesia 
carries a certain risk for the patient, especially if multi-morbidity is present. 
Section 11.4 provides a list of all potential (S)AEs that have either been observed during or after 
deep enteroscopy with PowerSpiral conducted in a clinical study setting or are anticipated. There 
is no additional device related new risk identified that was not already anticipated for its 
predecessor. 

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The overall risk / benefit ratio for this clinical investigation is assumed to be in the same 
acceptable range of established balloon assisted methods of deep enteroscopy. As mentioned 
earlier this registry does not impose any additional “protocol driven” interventions or examinations 
therefore the procedural risk to which a patient will be exposed to should be very similar to the 
risk in case he/she would not have agreed to participate in this study 
 

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2 
TRIAL OBJECTIVES 
2.1 
Objective 
The main objective of this registry is to collect data on the safety and performance of the new 
motorized PowerSpiral device when used as intended by the manufacturer. It is assumed that the 
new device and its safety profile is non-inferior to preceding generations of balloon assisted 
enteroscopes.  
As clinical performance and efficacy is equally important for the user this study also collects 
efficacy and handling data of the new device. 
With this registry OLYMPUS complies with Post-Market Clinical Follow-up (PMCF) requirements. 

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3 
DESIGN OF THE CLINICAL INVESTIGATION 
3.1 
General 
3.1.1 
Design Overview 
SAMISEN is an international, multicenter, non-randomized, prospective, observational open label 
(registry) study examining the CE- marked PowerSpiral (OLYMPUS PSF-1, SINGLE USE 
POWER SPIRAL TUBE and motor control unit POWER SPIRAL CONTROL) device. (For 
justification of the study design please refer to section 1.2) 
3.1.2 
Randomization and Blinding or Assignment of Investigational Device 
SAMISEN is designed as a prospective single-arm trial without control group or randomization. All 
subjects enrolled will undergo at least one procedure with the Motorized Spiral Endoscope 
(PowerSpiral). There may be a second (optional) procedure depending on investigator’s 
discretion usually because the region of interest could not be reached during the first endoscopy. 
Subsequent endoscopic procedures are often characterized by a switch in direction (a first 
antegrade route may be followed by a second retrograde approach or vice versa). From a study 
perspective and because only part of the subjects will receive a second procedure this additional 
procedure is called “optional” to indicate that it is not required by protocol but will only be 
performed if considered necessary by the treating investigator. 
3.1.3 
Variables in the Clinical Investigation 
It is a prospective and observational Registry without any additional procedure beyond clinical 
practice. The small-bowel enteroscopy has to be performed according the medical standard. 
Serious Adverse Events (SAE) and Device Deficiencies (DD) must be documented. 
The main safety endpoint is a combined one, capturing all SAEs / DDs captured during the study 
period. The definition is: 
• 
Safety: Incidence (% of subjects) and frequency (no. of subjects) of device or procedure 
related Serious Adverse Events (SAEs) and Device Deficiencies (DD) observed 
during/after the procedure. 
As main efficacy endpoint we will determine in how many cases the suspected anatomical target 
lesion can be reached. The definition is: 
• 
Diagnostic Yield: Defined as the percentage of procedures that either confirmed a 
diagnosis from previous studies, or established a new definitive diagnosis at the 
anatomical location identified in previous studies or findings that could explain the clinical 
symptoms (Sethi et al. 2014; Prachayakul et al. 2013; Lenz, Roggel, and Domagk 2013; 
Sanaka et al. 2012). 

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Further efficacy endpoints cover performance aspects of the device. The definitions are: 
• 
Therapeutic Yield: Defined as the percentage of patients with any endoscopic 
intervention / therapy with the exception of biopsies. (Sethi et al. 2014; Prachayakul et al. 
2013; Sanaka et al. 2012). 
• 
Total procedure time: the time from oral (anal) insertion until withdrawal of the device. 
• 
Total therapeutic intervention time: The part of the procedure dedicated to therapeutic 
maneuvers (biopsies will not be considered here). 
• 
Total small bowel enteroscopy rate: Defined as complete evaluation of the small bowel 
either with a single approach or combined anterograde and retrograde approach (if 
complete small bowel enteroscopy is intended anyway (Committee et al. 2015; Gerson et 
al. 2015). 
• 
User feedback and judgment of handling characteristics and other aspects.  
3.1.4 
Replacement of Subjects 
If subjects enrolled into this study withdraw their consent or drop out for other reasons before the 
small-bowel enteroscopy was actually performed the site shall continue to enroll subjects and 
conduct enteroscopies until the quota of 22 “subjects counting” for the site has been completed.  
Besides that, it is not foreseen to replace subjects that drop out after the first enteroscopy but 
before hospital discharge. 
3.2 
Investigational Device(s) and Comparators 
3.2.1 
Investigational Device(s) 
In this prospective Registry all investigators will deploy a motorized PowerSpiral device. There 
are no different (sub)types of this devices, so all devices used will be identical. 
3.2.2 
Comparator Devices(s) 
Not applicable. 
3.2.3 
Reference Device(s) 
Balloon assisted enteroscopy (BAE) devices used for deep enteroscopy and as described in the 
literature (Rondonotti et al. 2018) will serve as historical controls. 
3.2.4 
Other Medical Device / Medication 
Not applicable. 
3.3 
Subjects 
3.3.1 
Inclusion criteria 

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In order to be considered eligible for participation in this investigation subjects must meet all of 
the inclusion criteria listed below: 
• 
Signed informed consent 
• 
Patients with small bowel disease indicated for deep enteroscopy, including but not 
limited to: 
• 
Gastrointestinal bleeding  
• 
Crohn’s disease  
• 
Abdominal pain or chronic diarrhea  
• 
Large polyps (>10–15mm) in the jejunum and ileum in patients with Peutz–
Jeghers syndrome 
• 
Nonresponsive or refractory coeliac disease 
• 
Results and hints from other preliminary investigations, e.g. small-bowel 
capsule endoscopy, small-bowel imaging examinations etc. which warrant 
further work-up with antegrade and/or retrograde enteroscopy of the small-
bowel. 
3.3.2 
Exclusion criteria 
In addition to be eligible for study enrollment a subject must not meet any of the exclusion criteria 
listed below: 
• 
Age under 18 years 
• 
Female and of child-bearing age who is currently pregnant or planning to become 
pregnant within the study period 
• 
Any contraindication to standard enteroscopy (e.g. severe coagulopathy or known 
coagulation disorder; bowel obstruction / stenosis, stents or other instruments implanted 
in the intestinal tract, suspected GI perforation, esophageal or gastric varices, eosinophilic 
esophagitis) as judged by the investigator after careful individual risk assessment 
• 
Concurrent participation in another competing clinical study 
3.3.3 
Subject Withdrawal or discontinuation  
A subject may withdraw his/her consent to participation at any time without explanation and 
without consequences for further treatment. Moreover, the study treatment may be discontinued 
temporarily or permanently due to one of the following reasons:  
1. 
Any health deterioration of the subject, e.g. ALAT and/or ASAT > 3 times upper limit 
of normal range, 
2. 
Not acceptable further study participation as determined by the investigator, 
3. 
Occurrence of not tolerable adverse events and/or laboratory value alterations, 
4. 
Technical reasons (change of physician, change of address of subject), 

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5. 
Lacking compliance of subject, 
6. 
Pregnancy, 
7. 
Major CIP deviation, 
8. 
Subject lost to follow-up, 
9. 
Death. 
If a subject discontinues participation in the study after signing the consent for whatever reason, 
every effort has to be made to perform an early termination visit in case the antegrade and/or 
retrograde examination were already conducted. In this case, the same examinations as in the 
final visit (Visit 4) shall be performed. 
3.3.4 
Point of Enrolment 
Point of enrolment is defined as the time at which a subject dates and signs the informed 
consent. At least one day prior to that, the investigator shall provide a complete explanation of the 
study (benefits, risks, rights and obligations). 
3.3.5 
Duration of the Clinical Investigation 
The average duration of study participation for subjects completing the study is estimated to be 
approximately 2 days up to one week. It depends among others if only a single enteroscopy is 
planned or a combined antegrade and retrograde approach at two examination days. The 
estimated total study duration for the whole study cohort is approximately one year. The end of 
study is defined as the date of the database lock. 
3.3.6 
Sample size 
A total of 260 subjects shall be enrolled into this registry. This number factors in an expected 
drop-out-rate of 5%. Taking into account a drop-out-rate of 5% data from a total of 245 patients is 
expected to be available for statistical endpoints analyses.  
With a sample size of 245 patients, the SAE rate can be estimated with a precision (i.e. width of 
the 95% confidence interval for the SAE rate) as shown in the following table.  
 
 

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Table 1 Precision of estimations of the rate of patients with at least one SAE 
Sample size 
N 
Patients with 
SAE 
Rate of 
patients with 
SAE 
95% CI 
(Clopper-
Pearson) 
245 
5 
2.0% 
0.7% - 4.7% 
245 
10 
4.1% 
2.0% - 7.4% 
245 
15 
6.1% 
3.5% - 9.9% 
245 
20 
8.2% 
5.1% - 12.3% 
245 
25 
10.2% 
6.7% - 14.7% 
245 
30 
12.2% 
8.4% - 17.0% 
As historical control, a SAE rate of 8% is considered (upper limit of the accepted SAE rate for 
patients undergoing deep enteroscopy according to the guideline (Rondonotti et al. 2018)). 
In addition, to reflect the learning curve of each individual investigator, the first 5 patients per 
investigator will be considered training patients to become familiar with the handling and usage. 
All information of these “training patients” will be documented in the eCRF. These will be 
analyzed separately. 12 clinical sites in Germany, Belgium, France, Netherland, Italy, Denmark, 
Norway and Finland will be approached. At each site there will be either one or two investigators. 
Based on current information there will be approx. 15 investigators participating. Adding patients 
from the learning curve (15 x 5 = 75) and the 260 study patient’s counting towards the endpoints 
together this study will enroll approximately 335 patients in total.  
The enrolment period starts in May/June 2019 and will stop once the expected number of patients 
per site is reached. This “Last-Patient-In” (end of recruitment) is expected in May/June 2020. 
Each site with two investigators shall take every effort to enroll a balanced number of patients per 
investigator.  
Statistical Analyses will be performed with SAS software version 9.4 (SAS Institute Inc., Cary, 
NC, USA). 
 
 

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3.4 
Procedures 
3.4.1 
Overview of the Procedures and Laboratory Measurements 
Table 2 gives an overview of the relevant study procedures:  
 
Table 2 List of study procedures 
Visit 
V1 
V2 
V3 
V4 
 
Screening 
1st scheduled 
procedure 
2nd scheduled 
procedure 
(optional) 
Hospital 
discharge 
visit 
Patient informed 
consent 
x 
 
 
 
Inclusion/Exclusion 
criteria 
x 
 
 
 
Demographic data 
x 
 
 
 
Physical examination 
with vital signs, body 
measurements (body 
weight and body height) 
and concomitant 
diseases  
x 
 
 
 
Small-bowel 
enteroscopy with 
PowerSpiral 
 
x 
x 
 
Evaluation of criteria 
regarding usage of 
PowerSpiral  
 
x 
 
 
(Serious) Adverse 
Events 
 
x 
x 
x 
  
3.4.2 
Description of clinical investigation related procedures and assessed data  
At the screening visit the investigator informs the patient about the trial and selects the patient as 
potentially suitable for this trial. The patient should receive the patient information and patient 
consent sheet for information. An official Visit 1 will be arranged.  
The following data will be collected during the clinical investigation at the various study visits:  
 
At visit V1: 
At this visit the patient will be informed about the trial in detail and the patient consent must be 
signed at Visit 1 (or earlier). All questions of the patient shall be answered.  

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The following data shall be captured for all patients meeting the inclusion and exclusion criteria: 
• 
Demographic Data 
 Age 
 Sex  
• 
Physical Examination 
 Height 
 Weight 
 Radial pulse (with the subject in the supine position for at least 5 minutes before). 
 Blood pressure (according to Riva Rocci using calibrated sphygmomanometers, 
the subject has to be in a sitting position for at least 5 minutes, blood pressure will 
be measured twice within 5 minutes, the mean of both measurements will be 
calculated). 
 Document if a 12-lead ECG was recorded as medical standard in your hospital. 
 Document if a clinical standard panel of laboratory parameters is determined prior 
to small-intestine enteroscopy as medical standard in your hospital. Any deviation 
of laboratory parameters exceeding normal ranges shall be documented and 
followed up, as appropriate. Clinically significant deviations observed during the 
screening visit and throughout the study will be documented in the Case Report 
Form. 
 Select the appropriate ASA class1 1 to assess the fitness of the patient.  
 Document any abnormalities detected in one of the following organ systems: 
- 
Head, neck and thyroid (gland) 
- 
Skin and mucosa 
- 
Cardiovascular system 
- 
Respiratory system 
- 
Abdomen 
- 
Spine 
- 
Extremities 
- 
Reflexes 
- 
Other 
• 
Provide information about the following concomitant medication  
 Acetylsalicylic acid 
                                                   
1 We recommend to take the ASA class from the anesthesiologic pre-medication records 

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 Anticoagulant therapy 
 Discontinuation of Anticoagulant therapy prior / during the procedure 
• 
Provide information about the planned small-bowel enteroscopy  
 Main indication for the planned small- bowel enteroscopy procedure. 
 Select if a capsule endoscopy, CT/MRT enteroclysma or another imaging 
technique was performed previously. 
 Describe if there were any positive findings during the previous diagnostic workup 
(e.g. if a bleeding was detected). 
• 
Describe the initially planned PowerSpiral approach  
 Is a total enteroscopy of the small-bowel planned? 
 Start with antegrade procedure and add a retrograde one if unsuccessful or 
incomplete or  
 Start with retrograde procedure and add an antegrade one if the initial procedure 
is unsuccessful or incomplete or  
 Perform a combined antegrade and retrograde examination during a single 
session. 
 
At visit V2 and V3 (optional): 
• 
At this visit the PowerSpiral enteroscopy will be performed. 
• 
Enter the date and name of the responsible investigator who performs the enteroscopy. 
• 
Enter the total procedure time (“scope-in, scope-out”) measured from initial enteroscope 
introduction through the bite block to final enteroscope withdrawal through the bite block 
(minutes) (for antegrade approach) or crossing the linea dentata of the anus in case of a 
retrograde approach. 
• 
Provide information about the kind of staff and number persons needed for this 
enteroscopy. 
• 
Select if an antegrade, retrograde or combined enteroscopy was performed.  
• 
Select if a general anesthesia or sedation is used. 
• 
Select which part of the small-bowel was reached. 
• 
Answer if the findings of the previous imaging examinations were confirmed or not. 

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• 
Answer if there was any therapeutic intervention performed. If yes please specify in the 
free text section. 
• 
Enter the time needed for any therapeutic intervention. If several slots for therapeutic 
interventions occurred, please add the time needed for each therapeutic slot and enter 
the total duration in minutes.  
• 
Answer if any Serious Adverse Events occurred during the enteroscopy procedure. 
• 
Document the final diagnosis after the enteroscopy 
• 
Answer the following questions:  
 Was the therapeutic intervention successful and were all planned therapeutic 
aim(s) achieved? 
 Was the initial therapeutic management plan modified during the procedure? 
 Was total enteroscopy achieved? 
 Do you plan for another enteroscopy? 
After visit 2 the investigator shall give an evaluation of the PowerSpiral procedure in comparison 
to BAE medical devices for deep enteroscopy previously used. The investigator shall judge if the 
PowerSpiral is “worse”, “similar” or “better” than previous equipment used for the following topics: 
• 
Handling (Handling means the whole handling of the instrument (PowerSpiral scope + 
overtube + motor control unit) during preparation of the equipment and throughout the 
examination). 
• 
Instrument insertion (Instrument insertion means how the instrument could be inserted 
either in the antegrade or retrograde route (whichever was selected).  
• 
Precision of positioning during therapy (This means how precise and how stable the 
instrument could be positioned during a therapeutic intervention). 
• 
Time needed for procedure (It means the time duration describes the start as entering 
the endoscope in the mouth or anus until withdrawal which suppose as stop point). 
• 
Staff and resources required for procedure.  
Visit 3 is a second (optional) procedure depending on investigator’s discretion. 
In case the investigator plans a second approach a tattoo or clip should be set at the deepest part 
of the small-bowel before the investigator starts the withdrawal of the PowerSpiral.  

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At visit 4 
Visit 4 is the hospital discharge visit. The patient is ready to leave the hospital and the status shall 
be documented.  
The following data will be documented: 
• 
Date of the hospital discharge examination. 
• 
Actual discharge date. 
• 
if the patient has recovered from the examination. 
• 
Describe new (Serious) Adverse Event if any 
• 
Clinical signs or symptoms of pancreatitis e.g. elevated Lipase/Amylase (if measured 
post-procedure as medical standard in your hospital). 
• 
Specify if the patient get further treatment from the referral physician or if additional 
specialist(s) will be involved.  
The investigator will ensure that the patient receives further medication as necessary and can be 
discharged from hospital and consigned to GP’s or medical specialist’s care.  
Finally, the investigator shall to sign off the eCRF to confirm that the data is complete and 
accurate.   
3.4.3 
Study Visits Schedule 
After visit V1 the investigator will schedule the antegrade or retrograde or combined enteroscopy 
depending on investigator’s discretion. There are no predetermined time intervals between V1 
and V2 or V2 and V3. Also the standard preparation procedure in your hospital for defecation 
before small-bowel enteroscopy shall be followed as usual. 
The small-bowel enteroscopy duration depends on the individual diagnostic and treatment 
activities for each patient. Approximately 45 min are assumed for an uncomplicated antegrade 
examination. 
The final visit V4 shall be completed prior to hospital discharge. 
Premature study discontinuation of a study subject is to be noted as such on the case report form 
(eCRF). 
3.4.4 
Concomitant treatments 
Concomitant treatment during study participation should be in line with the medical standard for 
small-bowel enteroscopy. Information about Acetylsalicylic acid and Anticoagulant therapy must 
be documented in the eCRF. 

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3.4.5 
Medical Care after Termination of the Clinical Investigation 
At the final visit V4 the investigator will ensure that the patient can be discharged from hospital 
without any identifiable risk and that further treatment on an outpatient basis through a general 
practitioner or medical specialist will be provided as necessary. Any ongoing (serious) adverse 
events that deserve special attention shall be mentioned in the patient’s discharge letter.  
3.4.6 
Deviations from medical standard 
The observational character of this registry study does not require any additional clinical 
procedure or tests beyond standard of care. Any deviation for medical reasons shall be 
documented in the eCRF. 
3.5 
Monitoring Plan 
3.5.1 
Responsibilities 
Study monitoring will be performed by the 
 
 
The monitor will visit the study sites in order to check that eCRFs are completed without 
omission, and that Good Clinical Practice guidelines and the CIP are followed. He/she will also 
check the progress of subject inclusion. The monitor shall be granted access to the study binder 
and hospital records of enrolled subjects. The study nurse shall be available to the monitor during 
monitoring visit(s). The investigator is expected to be available at least for a debriefing at the end 
of the monitoring site visit. 
After study end the site will receive a copy of the eCRF file and the investigator has to ensure that 
it is stored safely with all other study documents filed in the Investigator Site File according to 
national law. 
3.5.2 
Source Data Definition and Verification (SDV) 
Source data are the original records of all variables collected for the clinical investigation. They 
include, but are not limited to: 
• 
Signed informed consent, 
• 
Laboratory reports, 
• 
Individual subject clinical notes, 
• 
Hospital charts or pharmacy records and any other similar reports and records of any 
procedure performed in accordance with the CIP, 
• 
Details concerning inclusion and exclusion criteria. 
The investigator must allow the monitor access to all documents in the medical file to confirm 
their consistency with the electronic case report form entries. All information entered in the eCRF 
must be available as source data. No information about subject identity on these documents will 

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be allowed to leave the study site. At a minimum the following points will be verified by the 
monitor: existence of signed informed consent, adherence to inclusion/exclusion criteria, all SAEs 
and a tabulation of adverse events. Further checks may be carried out according to the study 
specific monitoring plan to confirm matching of all eCRF data matches source data. 
For more details on Monitoring of this Clinical Investigation please refer to the “Monitoring Plan” 
(available upon request). 

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4 
STATISTICIS 
Statistical analysis of the data will be performed by 
. The 
evaluation will be specified in the Statistical Analysis Plan (SAP) laid down in a separate 
document.  
Demographic data, baseline characteristics and information of the physical examination and 
medical history with concomitant medication will be reported in summary tables. Additional 
information about the planned small-bowel enteroscopy will be reported. 
4.1 
Statistical methods 
4.1.1 
Background and demographic characteristics 
Continuous variables such as age will be presented by mean, standard deviation, minimum, 
median and maximum. Categorical data such as gender will be presented as absolute and 
relative frequencies. 
All variables with no coding available will be listed.  
4.1.2 
Efficacy evaluation 
The efficacy endpoints are defined as follows: 
• 
Reaching the anatomical region of interest: The rate of successfully reaching the 
suspected anatomical target region (either by antegrade or by retrograde route) 
compared to all attempts represents the anatomical success rate. 
• 
Therapeutic Yield: Defined as the percentage of patients with any endoscopic 
intervention / therapy with the exception of biopsies. (Sethi et al. 2014; Prachayakul et al. 
2013; Sanaka et al. 2012). 
• 
Total procedure time. 
• 
Total therapeutic intervention time: period in min dedicated to therapeutic 
intervention(s). 
• 
Total small bowel enteroscopy rate: Defined as complete evaluation of the small bowel 
either with a single approach or combined anterograde and retrograde approach (if 
complete small bowel enteroscopy is intended anyway (Committee et al. 2015; Gerson et 
al. 2015). 
• 
User feedback and judgment of handling characteristics and other aspects. 

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• 
User feedback and assessment of handling characteristics and other logistical aspects 
regarding: 
o 
Handling of PowerSpiral 
o 
Instrument insertion of PowerSpiral 
o 
Precision of positioning during therapy of PowerSpiral 
o 
Time needed for procedure of PowerSpiral 
o 
Staff and resource needed for procedure of PowerSpiral 
No hypothesis testing will be performed for any efficacy endpoint. 
4.1.3 
Safety evaluation 
The following safety variables will be collected: 
• 
Serious adverse events during and after enteroscopy procedure  
• 
Serious adverse events (procedure or product related) 
• 
Adverse events during enteroscopy procedure  
The safety variables will be tabulated for all study participants. 
Adverse events data will be processed in the statistical analysis after coding. 
AEs and device deficiencies will be presented in summary tables. These tables will show the 
number of subjects per group presenting an adverse event and the incidence of its occurrence. 
Adverse events will be grouped by system organ class and stratified by severity (mild, moderate, 
severe) and by relation to study treatment (unrelated or related according to the categories 
definite, probable and possible). 
4.1.4 
Interim analysis 
Not planned. 
4.1.5 
Other evaluations  
Not planned. 
4.2 
Subgroup Analyses 
 No subgroup analysis planned. 
4.3 
Missing/spurious Data 
All available data will be included in the analyses and will be summarized as far as possible. 
Unless otherwise specified there will be no substitution of missing data, i.e. missing data will not 
be replaced, missing data will be handled as 'missing' in the statistical evaluation. 

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5 
DATA MANAGEMENT 
5.1 
Data recording 
Data shall be recorded in the eCRFs in a timely manner but not later than 5 working days after 
collection of the data, including signatures. Please take into account, a SAE must be documented 
immediately to meet the reporting requirements. The investigator must document all visits and 
assessments on the respective eCRF form and shall ensure that no empty data blocks exist. If a 
test or assessment was not performed, the investigator shall indicate this. If a question does not 
apply, the investigator shall also document this (e.g. by entering “NA”). 
The investigator shall sign the overall affirmation statement for each patient to document personal 
responsibility for accuracy, completeness of data captured in the system and for the trial being 
carried out according to the protocol and any amendments.  
Data can only be entered by authorized and trained site staff, i.e. by the investigator or 
investigator’s staff trained on eCRF procedures. (S)AE pages must be signed off by the 
investigator. 
Data corrections in the eCRF done by the investigator or designee require entering a reason for 
the data change. The change of already entered data and the person who performed the data 
change will be tracked in the audit trail of the eCRF. In case of data changes in the eCRF that 
has already been signed off a new signature is required to authorize the data modification.  
Queries issued within the eCRF shall be answered within 7 working days. 
5.2 
Data processing 
Data processing, controls of plausibility and query handling will be carried out by the 
 
. The study database will be created 
according to the format and content of the eCRF and the CIP. The ICD-10 code will be used for 
coding of adverse events and previous / concomitant diseases.  

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6 
AMENDMENTS TO THE CIP 
CIP amendments or supplements (apart from minor administrative changes) require a written 
amendment. Amendments must be approved by the EC and the regulatory authorities, if locally 
applicable, before implementation. A copy of the written approvals will be provided to the 
investigators. 
The following list provide an overview about the changes compare to CIP version no. 01 from 20. 
December 2018. 
Table 3 List of changes CIP version 01 versus CIP version 02. 
Amend-
ment  
no. 01 
Section 
Previous version 
CIP version 01 from 20th Dec 2018 
Changed Version 
CIP version 02 from 23 April 2019 
 
Trial 
summary  / 
endpoints 
Endpoints 
…. 
• 
Endoscopic and ERCP 
success rates in patients with 
altered upper GI anatomy (e.g. 
Roux-en-Y gastric bypass). 
Endpoints 
 
…… 
• 
Endoscopic success rates.   
 
 
Trial 
summary/S
tudy 
Population 
 
Inclusion criteria 
1. Signed informed consent 
2. Patients with small bowel 
disease indicated for deep  
enteroscopy, including but not 
limited to: 
• 
Gastrointestinal bleeding  
• 
Crohn’s disease  
• 
Abdominal pain or chronic 
diarrhea  
• 
Large polyps (>10–15mm) 
in the jejunum and ileum in 
patients with Peutz–
Jeghers syndrome 
• 
Nonresponsive or refractory 
coeliac disease 
• 
Results and hints from 
other preliminary 
investigations, e.g. small-
bowel capsule endoscopy, 
small-bowel imaging 
examinations etc. which 
warrant further work-up 
with antegrade and/or 
retrograde enteroscopy of 
the small-bowel.  
or 
• 
Patients with altered upper 
GI anatomy (e.g. Roux-en-
Y or BII) indicated for 
Inclusion criteria 
1. Signed informed consent 
2. Patients with small bowel disease 
indicated for deep  enteroscopy, 
including but not limited to: 
• 
Gastrointestinal bleeding  
• 
Crohn’s disease  
• 
Abdominal pain or chronic 
diarrhea  
• 
Large polyps (>10–15mm) in 
the jejunum and ileum in 
patients with Peutz–Jeghers 
syndrome 
• 
Nonresponsive or refractory 
coeliac disease 
• 
Results and hints from other 
preliminary investigations, e.g. 
small-bowel capsule 
endoscopy, small-bowel 
imaging examinations etc. 
which warrant further work-up 
with antegrade and/or 
retrograde enteroscopy of the 
small-bowel.  
 

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ERCP where access with 
conventional ERCP devices 
is of no avail and after 
careful individual risk 
assessment 
1 
BACKGRO
UND AND 
RATIONAL
E 
Small bowel enteroscopy is usually 
performed 
in 
order 
to 
evaluate 
gastrointestinal bleeding, small bowel 
tumors, polyps, inflammatory or other 
small bowel diseases. Video capsule 
endoscopy, single- (SBE), double-
balloon (DBE) or spiral enteroscopy 
are the most popular non-surgical 
endoscopic 
techniques 
in 
this 
context. 
Hereof 
the 
endoscopic 
approach offers additional diagnostic 
and therapeutic options as biopsies 
and direct therapeutic intervention is 
possible 
compared 
to 
capsule 
endoscopy. 
These 
enteroscopy 
systems – also called overtube-
assisted 
enteroscopy 
(OAE) 
techniques - are used to visualize the 
small-bowel and proceed with a 
therapeutic intervention, either during 
the same or in a subsequent session. 
For example the DBE utilizes distal 
and proximal balloons that can be 
inflated and deflated to “anchor” and 
move the bowel, thereby assisting 
the 
operator 
in 
advancing 
the 
endoscope while gathering the bowel 
onto the overtube shaft. 
However, 
the 
SBE 
and 
DBE 
procedures are time consuming and 
usually 
require 
2 
operators 
to 
perform this kind of examination.  
Patients 
with 
altered 
upper 
gastrointestinal (upper GI) anatomy 
(such as Roux-en-Y gastric bypass) 
indicated for endoscopic retrograde 
cholangiopancreatography 
(ERCP) 
represent a special challenge to the 
investigator. The new endoscopic 
techniques originally designed for 
deep enteroscopy have increased 
the potential to reach the area of 
interest and successfully perform 
ERCP and therapeutic interventions 
at acceptable complication rates 
(Skinner et al. 2014). This has led to 
increasing 
acceptance 
of 
OAE 
techniques in this special patient 
cohort. 
 
Small bowel enteroscopy is usually 
performed 
in 
order 
to 
evaluate 
gastrointestinal bleeding, small bowel 
tumors, polyps, inflammatory or other 
small bowel diseases. Video capsule 
endoscopy, 
single- 
(SBE), 
double-
balloon (DBE) or spiral enteroscopy are 
the 
most 
popular 
non-surgical 
endoscopic techniques in this context. 
Hereof the endoscopic approach offers 
additional diagnostic and therapeutic 
options 
as 
biopsies 
and 
direct 
therapeutic 
intervention 
is 
possible 
compared to capsule endoscopy. These 
enteroscopy systems – also called 
overtube-assisted enteroscopy (OAE) 
techniques - are used to visualize the 
small-bowel 
and 
proceed 
with 
a 
therapeutic intervention, either during 
the same or in a subsequent session. 
For example, the DBE utilizes distal and 
proximal balloons that can be inflated 
and deflated to “anchor” and move the 
bowel, thereby assisting the operator in 
advancing 
the 
endoscope 
while 
gathering the bowel onto the overtube 
shaft. 
However, the SBE and DBE procedures 
are time consuming and usually require 
2 operators to perform this kind of 
examination.  
1.2. 
Justification 
for the 
… 
For 
the 
same 
reason 
inclusion 
criteria are kept as broad as possible. 
…. 
For the same reason inclusion criteria 
are kept as broad as possible. In 

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Design of 
the Clinical 
Investigatio
n 
 
 
In summary all patients are eligible 
where the physician realizes an 
indication for deep enteroscopy for 
further diagnostic or therapeutic work 
up. In patients with altered upper GI 
anatomy, such as e.g. Roux-en-Y 
gastric bypass indicated for ERCP is 
in line with the intended use and 
hence can be performed using 
PowerSpiral if deemed appropriate 
by the investigator. So inclusion of 
these patients into this registry is 
possible.  The exclusion criteria will 
only affect patients under the age of 
18 years and pregnant women. 
Otherwise clinical judgement of the 
treating physician is the only relevant 
and leading reason for exclusion. Of 
course 
giving 
signed 
informed 
consent by all study subjects is a 
prerequisite for participation in this 
“registry”. 
 
summary all patients are eligible where 
the physician realizes an indication for 
deep enteroscopy for further diagnostic 
or therapeutic work up.    The exclusion 
criteria will only affect patients under the 
age of 18 years and pregnant women. 
Otherwise clinical judgement of the 
treating physician is the only relevant 
and leading reason for exclusion. Of 
course giving signed informed consent 
by all study subjects is a prerequisite for 
participation in this “registry”. 
 
3.1.3 
Variables in 
the Clinical 
Investigatio
n 
 
…… 
• 
Total 
small 
bowel 
enteroscopy rate: Defined 
as complete evaluation of the 
small bowel either with a 
single approach or combined 
anterograde and retrograde 
approach (if complete small 
bowel 
enteroscopy 
is 
intended anyway (Committee 
et al. 2015; Gerson et al. 
2015). 
• 
User 
feedback 
and 
judgment 
of 
handling 
characteristics 
and 
other 
aspects. 
• 
For “ERCP patients” 2only:  
o 
Endoscopic 
Success 
Rate: 
defined 
as 
the 
percentage 
of 
procedures in which 
the investigator was 
able to reach the 
major papilla or the 
biliodigestive 
or 
pancreatic 
anastomosis 
when 
ERPC was planned. 
o 
ERCP 
Success 
Rate: defined as the 
……….. 
• 
Total 
small 
bowel 
enteroscopy rate: Defined as 
complete 
evaluation 
of 
the 
small bowel either with a single 
approach 
or 
combined 
anterograde 
and 
retrograde 
approach (if complete small 
bowel enteroscopy is intended 
anyway (Committee et al. 2015; 
Gerson et al. 2015). 
• 
User feedback and judgment 
of handling characteristics and 
other aspects. 
 
                                                   
2 Patients with altered upper GI anatomy now indicated for ERCP with PowerSpiral as judged by the 
investigator 

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percentage 
of 
therapeutic 
interventions 
successfully 
completed 
by 
the 
investigator. 
o 
Total 
procedure 
time, safety related 
aspects 
and 
user 
feedback 
will 
be 
collected 
as 
described above. 
 
3.3.1 
Inclusion 
criteria 
 
 
In order to be considered eligible for 
participation 
in 
this 
investigation 
subjects must meet all of the 
inclusion criteria listed below: 
• 
Signed informed consent 
• 
Patients with small bowel 
disease indicated for deep 
enteroscopy, including but 
not limited to: 
• 
Gastrointestin
al bleeding  
• 
Crohn’s 
disease  
• 
Abdominal 
pain or chronic 
diarrhea  
• 
Large 
polyps 
(>10–15mm) 
in the jejunum 
and ileum in 
patients 
with 
Peutz–Jeghers 
syndrome 
• 
Nonresponsive 
or 
refractory 
coeliac 
disease 
• 
Results 
and 
hints 
from 
other 
preliminary 
investigations, 
e.g. 
small-
bowel capsule 
endoscopy, 
small-bowel 
imaging 
examinations 
etc. 
which 
warrant further 
work-up 
with 
antegrade 
and/or 
retrograde 
enteroscopy of 
In order to be considered eligible for 
participation 
in 
this 
investigation 
subjects must meet all of the inclusion 
criteria listed below: 
• 
Signed informed consent 
• 
Patients 
with 
small 
bowel 
disease 
indicated 
for 
deep 
enteroscopy, including but not 
limited to: 
• 
Gastrointestinal 
bleeding  
• 
Crohn’s disease  
• 
Abdominal 
pain 
or 
chronic 
diarrhea  
• 
Large 
polyps 
(>10–15mm) 
in 
the jejunum and 
ileum in patients 
with 
Peutz–
Jeghers 
syndrome 
• 
Nonresponsive or 
refractory coeliac 
disease 
• 
Results and hints 
from 
other 
preliminary 
investigations, 
e.g. small-bowel 
capsule 
endoscopy, 
small-bowel 
imaging 
examinations etc. 
which 
warrant 
further 
work-up 
with 
antegrade 
and/or retrograde 
enteroscopy 
of 
the small-bowel. 
 

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the 
small-
bowel. 
                           or 
• 
Patients 
with 
altered 
upper 
GI 
anatomy 
(e.g. Roux-en-
Y 
or 
BII) 
indicated 
for 
ERCP 
where 
access 
with 
conventional 
ERCP devices 
is of no avail 
and 
after 
careful 
individual risk 
assessment 
 
3.4.2 
Description 
of 
clinical 
investigatio
n 
related 
procedures 
and 
assessed 
data 
At visit V2 and V3 (optional): 
• 
At this visit the PowerSpiral 
enteroscopy 
will 
be 
performed. 
It 
is 
recommended to plan and 
perform an ERCP procedure 
only 
after 
the 
individual 
investigator’s learning curve 
(patient #1 to #5) has been 
completed. 
 
At visit V2 and V3 (optional): 
At 
this 
visit 
the 
PowerSpiral 
enteroscopy will be performed. 
4.1.2 
Efficacy 
evaluation 
 
• 
For “ERCP patients” only:  
o 
Endoscopic 
Success 
Rate: 
defined 
as 
the 
percentage 
of 
procedures in which 
the investigator was 
able to reach the 
major papilla or the 
biliodigestive 
or 
pancreatic 
anastomosis 
when 
ERPC was planned. 
o 
ERCP 
Success 
Rate: defined as the 
percentage 
of 
therapeutic 
interventions 
successfully 
completed 
by 
the 
investigator 
o 
Total 
procedure 
time, safety related 
aspects 
and 
user 
feedback 
will 
be 
collected 
as 
-/- 

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described above 
 
4.2  
Subgroup 
Analyses 
 
Patients indicated for ERCP with PS 
will be analyzed separately.  
No subgroup analysis planned. 
 
 
7.1. 
CIP 
deviation 
Major CIP deviations are, but are not 
restricted to  
• 
Deviation from the in- and 
exclusion criteria 
• 
Performing ERCP before the 
individual learning curve (5 
PS procedures performed as 
deep enteroscopy) has been 
completed. 
Major CIP deviations are, but are not 
restricted to  
• 
Deviation from the in- and 
exclusion criteria 
 
 

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7 
CIP DEVIATIONS 
The investigator must not deviate from the procedures described in this CIP.  
Under emergency circumstances, deviations from the CIP to protect the rights, safety and well-
being of human subjects may proceed without prior approval of the sponsor and the EC. Such 
deviations must be documented and reported to the sponsor and the EC as soon as possible.  
Classifications into minor and major CIP deviations will be performed by the clinical operations 
manager and statistician at the end of the study.  
Major CIP deviations are, but are not restricted to  
• 
Deviation from the in- and exclusion criteria 
 

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8 
DEVICE ACCOUNTABILITY 
This study is a post-market study. The PS enteroscopes are CE-marked. Hence from a regulatory 
perspective strict device accountability is not needed. However, the sponsor will have a list of 
serial numbers and can track which device was delivered to which study site. 
The devices are usually purchased by the site. Olympus will provide devices as loaner equipment 
to a limited number of sites serving as centers of excellence. Any loaner equipment shall be 
exclusively used for the examination of study patients. After reaching the agreed quota per site (5 
learning curve patients per investigator + 22 subjects counting towards the endpoints) the device 
must be returned to Olympus. Details are specified in the Clinical Trial Agreements. 
 

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9 
STATEMENT OF COMPLIANCE 
9.1 
Ethical and Regulatory Aspects 
The clinical investigation will be carried out in accordance with the following texts:  
• 
The Declaration of Helsinki (1996) 
• 
Good Clinical Practice (ICH E6) (current version) 
• 
DIN EN ISO 14155:2011 
The clinical investigation will not begin until the required approval / favorable opinion from the EC 
and / or regulatory authority (if applicable) have been obtained. Any additional requirements 
imposed by the EC or regulatory authority will be followed.  
Regulatory reporting responsibilities are specified in the respective Clinical Trial Agreements that 
also need to be duly signed prior to the first enrollment.  
Quality Control and Quality Assurance systems will ensure that the clinical investigation is 
conducted according to local law and Good Clinical Practices. Olympus Europa SE & Co. KG will 
follow their own Standardized Operating Procedures covering all aspects of the clinical 
investigation. 
9.2 
Patient Coverage 
The PowerSpiral medical device is a CE-certified and CE-marked product. Any patient product 
liability claims will be covered in accordance with the applicable product liability law. Additional 
patient coverage will be provided by the sponsor if required by national law. 
9.3 
Retention of Documents 
The investigator must conduct the study in compliance with the Medical Devices Act and Good 
Clinical Practices. The study documents comprise the following: 
• 
Case report forms, 
• 
Data correction/clarification forms, 
• 
Source documents, 
• 
Correspondence between sponsor/CRO and investigator, 
• 
Regulatory documents such as: 
o 
Signed CIP and any amendments, 
o 
EC approval and correspondence, 
o 
Curriculum Vitae of medical personnel (investigators, study nurses, etc.), 
o 
Subject signed consent forms, 

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o 
Investigator’s contract 
Source documents for study subjects shall be marked with the CIP Reference number [2018-GI 
(OEKG) -01]. 
The CIP, case report forms, correspondence, original informed consent forms, subject 
identification log with names of the patients and other documents concerning the study must be 
kept by the investigator in the investigator site file according to local regulations. The safekeeping 
period is usually 15 years after study close-out.  
9.4 
Auditing procedures 
National or foreign Health authorities may want to inspect your site at any time during or after the 
study. By participating in this clinical investigation investigators agree to and will grant authorized 
inspectors access to all original documents, including subject files. If subject files or medical 
records are stored on a computer system, the investigator (or delegate) shall ensure that data 
requested by the inspector is printed on paper, dated and signed before handed over to the 
inspector. Inspectors do not have direct access to the sites computer system. 
Also the sponsor (Olympus Europa SE & Co. KG) reserves the right to perform an audit during 
the active study phase or after study closeout. 

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10 
INFORMED CONSENT 
Before enrolment in the clinical investigation, the investigator must make sure that all eligible 
subjects are well provided with detailed information, both orally and in writing, about the following 
points in particular: 
• 
Aims, duration and methods of the clinical investigation. 
• 
Risks, anticipated benefits and potential hazards according to current knowledge. 
• 
That he/she is free to withdraw his/her consent at any time without affecting subsequent 
treatment or his/her relation to the physician. 
• 
That the clinical research monitors and auditors, Health Authority Inspectors and EC/IRB 
members may have access to their clinical source data.  
Informed consent must be given by a standard written declaration drafted in simple non-technical 
language. Subjects will also be informed that the data collected during the study will be archived 
and processed in accordance with local individual data protection law. 
The subject must read and understand the contents of this form before signing and dating it. 
He/she has to be provided with a signed version. No subject may be enrolled in this clinical 
investigation before giving his/her informed consent in writing. 
The investigator will inform all subjects included in the clinical investigation about any new 
information on the investigational device discovered during the study, in accordance with the 
recommendations of Olympus Europa SE & Co. KG, the sponsor, and the EC. 
The investigator must hold an updated list of all subjects enrolled in the study by recording their 
subject number. A Subject Identification Log Template will be provided by the sponsor. 

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11 
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE 
DEFICIENCIES 
11.1 Definitions (according to ISO 14155:2011) 
11.1.1 
Adverse event (AE) 
The term AE describes any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including laboratory values) in subjects, users or other persons, whether 
or not related to the investigational medical device. For subjects this definition includes: 
• 
Events related to the investigational medical device 
• 
Events related to the procedures involved  
• 
For users or other persons, this definition is restricted to events related to investigational 
medical devices 
Note:  
A “significant deterioration in laboratory parameters“ means an abnormal lab value, which is 
deemed clinically significant when any of the following conditions is met: 
• 
The abnormality suggests a disease and/or organ toxicity that is new or has worsened 
from baseline. 
• 
The abnormality is of a degree that requires additional active management, e.g. change 
of treatment, discontinuation of treatment, close observation, more frequent follow-up 
assessments, or further diagnostic investigation. 
Therefore, a clinically significant deterioration of a lab value is one that indicates a new disease 
process, worsening of an existing condition, or requires further action(s) to be taken. 
11.1.2 
Adverse Device Effect (ADE)  
An ADE is an adverse event related to the use of an investigational medical device. 
Note: 
• 
This definition includes any adverse event resulting from insufficiencies or inadequacies 
in the instructions for use, the deployment, the implantation, the installation, the operation, 
or any malfunction of the investigational medical device. 
• 
This definition includes any event that is a result of a use error or intentional misuse. 
• 
This includes medical devices already on the market that are being evaluated for 
unintended uses, new populations, new materials or design changes. 

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11.1.3 
Serious Adverse Event / Serious Adverse Device Effect (SAE /SADE) 
A SAE/SADE is further specified by the fact that it results or could have resulted in death or 
severe deterioration of health of a subject, user, or other persons, whether (SADE) or not (SAE) 
related to the investigational medical device. 
The criteria for a Serious Adverse Event (SAE) are the following:  
• 
Led to a death,  
• 
Led to a serious deterioration in health of the subject, that either resulted in:  
o 
A life-threatening illness or injury, or  
o 
A permanent impairment of a body structure or a body function, or  
o 
In-patient or prolonged hospitalization, or  
o 
In medical or surgical intervention to prevent life threatening illness or injury or 
permanent impairment to a body structure or a body function, 
• 
Led to fetal distress, fetal death or a congenital abnormality or birth defect.  
Note: Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, 
without serious deterioration in health, is not considered a serious adverse event. 
The following points should be taken into account when evaluating the seriousness of an Adverse 
Event: 
• 
The life-threatening criterion indicates that there was an immediate risk of death at the 
time of its occurrence. This does not mean that if the adverse event had occurred in a 
more severe form it would have led to death. 
• 
The following events are not considered to be serious adverse events: 
o 
An event causing a brief visit to a hospital consultation, an open-door or day 
hospital. 
o 
Outpatient treatment in the emergency department although the reason for which 
this treatment was instituted may be serious. 
o 
Admission to hospital (more than one night in a hospital bed) including surgical 
operations planned before or during the study if the condition was present before 
the study and provided that it does not worsen during the study. 
Note:  
A state of pregnancy is an exclusion criterion. Hence contraceptive measures must be taken by 
all subjects of childbearing potential throughout the study. However, if pregnancy is discovered 
during the study, the study participation must be discontinued immediately and the outcome of 
the pregnancy must be followed up carefully. Any abnormal outcome of the child or the mother 
must be documented.  

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11.1.4 
Device Deficiencies 
Device Deficiencies means any inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance 
11.2 Documentation  
11.2.1 
(Serious) Adverse Events / Adverse Device Effects 
Independent from a possible relation to the investigational device, every AE spontaneously 
reported by the subject or observed by the investigator has to be reported on the appropriate 
page of the case report form. Furthermore, the investigator shall actively ask the subject about 
the occurrence of any (S)AE at each visit and note any abnormal laboratory findings. For each 
adverse event the following information should be documented: 
• 
Description of the event (diagnosis and symptoms in verbatim terms), 
• 
Outcome, 
• 
Seriousness, 
• 
Duration (start date and stop date), 
• 
Causal relationship to the investigational device.  
Causality assessment will be done by the investigator using a 5-category system (no 
related / unlikely / possible / probable / causal relationship). 
• 
Any therapy or corrective action initiated including.  
The results of any complementary tests performed (laboratory tests, ECG, etc.) must be 
pseudonymized by the investigator prior to forwarding information to the sponsor. A period of 4 
weeks for follow up of AEs after the subject has routinely completed or prematurely terminated 
the study seems sufficient. This means that any additional information needed to assess the 
(S)AE should be collected and documented in the respective CRF within one month after 
occurrence. 
11.2.2 
Device deficiencies 
Two device deficiencies of the disposable Spiral Segment were documented in previous clinical 
studies with PowerSpiral. The technical issues are addressed and solved.  
11.3 Reporting Responsibilities 
11.3.1 
Serious Adverse Events (SAE) / Serious Adverse Device Effects (SADE) 
After the signature on the consent form is obtained, any SAE occurring while the subject is 
enrolled in the study must be immediately reported by the investigator.  
 
 

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11.3.1.1 
Serious Adverse Event - Initial Report 
The investigator has to report every SAE immediately after he/she becomes aware of the SAE.  
The Sponsor compile an accumulated SAE list and share with Ethical Committees on a bi-annual 
basis (if requested by the respective Ethical Committees). However, for international safety 
reporting requirements the sponsor needs to be informed immediately about any observed SAE.  
11.3.1.2 
Serious Adverse Event - Follow-up Report 
If the event / SAE is not resolved further information (e.g. laboratory reports, surgical reports) for 
full assessment is needed and shall be provided as soon as it becomes available. The sponsor 
may request additional documents, shall be provided within 5 days. 
11.3.2 
Device deficiencies 
Device deficiencies shall be reported to the sponsor not later than 7 working days after 
observation. 
11.3.3 
Responsible Nominated Safety Contact 
 
 
 
 
 
 
 
11.4 Anticipated Adverse Events 
Foreseeable risks include those typically associated with deep enteroscopy performed under 
general anesthesia or sedation.  
The following device and process related events were observed in previous Investigator-Initiated-
Trials with PowerSpiral. The SAMISEN study will contribute and extend the safety profile of the 
PowerSpiral device. 
 
 
 

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Table 4 List of anticipated (Serious) Adverse Events 
• 
mucosal damage 
• 
mucosal abrasion 
• 
mucosal inflammation 
• 
bleeding 
• 
hematoma 
• 
perforation 
• 
infection 
• 
pain (such as abdominal pain and sore throat) 
• 
abdominal distention 
• 
discomfort (such as  abdominal discomfort and swallowing discomfort) 
• 
digestive dysfunction (such as indigestion, nausea, vomiting) 
• 
cardiovascular problem (bradycardia, tachycardia, hypotension and 
hypertension) 
• 
dysphagia (such as odynophagia) 
• 
respiratory system disorder (such as aspiration pneumonia, cough, hypoxemia 
and mediastinal emphysema)  
• 
pancreatitis 
• 
fever 
• 
hyperamylasemia 
• 
hyperlipasemia 
• 
intestinal obstruction 
• 
intestinal necrosis 
• 
intussusception 
• 
parotitis 
• 
hiccup 
• 
electrification 
• 
burn 
• 
foreign body retention 
• 
intoxation 
• 
gas embolism 
• 
mucosal paratripsis 
• 
cut 
11.5 Data Monitoring Committee 
 Not applicable. 

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12 
VULNERABLE POPULATION 
 It is not planned to include a vulnerable population. 

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13 
SUSPENSION OR PREMATURE TERMINATION 
Certain circumstances may lead to early termination of an entire clinical investigation, in particular 
for ethical or safety reasons such as: 
• 
The high frequency and/or unexpected severity of adverse events. 
• 
Unsatisfactory recruitment of subjects as far as their quantity or quality is concerned or 
recurrent incomplete/inappropriate collection of data. 
The decision to put a study on hold or for premature termination will be made by the Sponsor. 

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14 
PUBLICATION POLICY 
The sponsor is explicitly committed to publish the trial results in a scientific medical journal and / 
or presented at scientific meetings. The Investigator agrees that any publication by the Study Site 
of study results conducted at their study site shall not be made before the first multicenter 
publication and as agreed between the sponsor and the Coordinating Clinical Investigator.  
For greater certainty, it is hereby recalled that in its capacity as sponsor of the trial, Olympus 
Europa SE & Co. KG is solely responsible to co-ordinate the publications of multicenter clinical 
trials in order to ensure that the related results are reported in a coherent and responsible manner 
so that results from clinical trial data subsets are not published in advance of or without clear 
reference to the primary publication and/or do not repeat such primary publication. Olympus 
Europa SE & Co. KG decides about the nomination of investigators as authors on the basis of its 
internal policies, requirements of the publishers and generally accepted standards of authorship. 
Therefore, Olympus Europa SE & Co. KG shall be duly informed of any publication plans in order 
to review any proposed manuscript before submission for publication. 

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15 
BIBLIOGRAPHY 
Akarsu, M., S. Akkaya Ozdinc, A. Celtik, and H. Akpinar. 2014. 'Diagnostic and therapeutic efficacy of 
double-balloon endoscopy in patients with small intestinal diseases: single-center experience 
in 513 procedures', Turk J Gastroenterol, 25: 374-80. 
Akerman, Paul A., and Daniel Cantero. 2009. 'Severe Complications of Spiral Enteroscopy in the First 
1750 Patients', Gastrointestinal Endoscopy, 69. 
Aktas, H., L. de Ridder, J. Haringsma, E. J. Kuipers, and P. B. Mensink. 2010. 'Complications of 
single-balloon enteroscopy: a prospective evaluation of 166 procedures', Endoscopy, 42: 365-
8. 
Arulanandan, A., P. S. Dulai, S. Singh, W. J. Sandborn, and D. Kalmaz. 2016. 'Systematic review: 
Safety of balloon assisted enteroscopy in Crohn's disease', World J Gastroenterol, 22: 8999-
9011. 
Beyna, T., M. Schneider, D. Pullmann, C. Gerges, J. Kandler, and H. Neuhaus. 2018. 'Motorized spiral 
colonoscopy: a first single-center feasibility trial', Endoscopy, 50: 518-23. 
Beyna, T; Arvanitakis, M; Schneider, M. et al. 2018. 'Motorized spiral enteroscopy: final results a 
two-center prospective clinical trial', United European Gastroenterology Journal. 
Committee, Asge Standards of Practice, M. A. Khashab, S. F. Pasha, V. R. Muthusamy, R. D. Acosta, 
D. H. Bruining, V. Chandrasekhara, K. V. Chathadi, M. A. Eloubeidi, R. D. Fanelli, A. L. Faulx, 
L. Fonkalsrud, S. R. Gurudu, L. R. Kelsey, S. Kothari, J. R. Lightdale, J. R. Saltzman, A. 
Shaukat, A. Wang, J. Yang, B. D. Cash, and J. M. DeWitt. 2015. 'The role of deep 
enteroscopy in the management of small-bowel disorders', Gastrointest Endosc, 82: 600-7. 
Gerson, L. B., J. L. Fidler, D. R. Cave, and J. A. Leighton. 2015. 'ACG Clinical Guideline: Diagnosis 
and Management of Small Bowel Bleeding', Am J Gastroenterol, 110: 1265-87; quiz 88. 
He, Q., Y. Bai, F. C. Zhi, W. Gong, H. X. Gu, Z. M. Xu, J. Q. Cai, D. S. Pan, and B. Jiang. 2013. 
'Double-balloon enteroscopy for mesenchymal tumors of small bowel: nine years' experience', 
World J Gastroenterol, 19: 1820-6. 
Lenz, P., M. Roggel, and D. Domagk. 2013. 'Double- vs. single-balloon enteroscopy: single center 
experience with emphasis on procedural performance', Int J Colorectal Dis, 28: 1239-46. 
Mans, L., M. Arvanitakis, H. Neuhaus, and J. Deviere. 2018. 'Motorized Spiral Enteroscopy for Occult 
Bleeding', Dig Dis, 36: 325-27. 
Moeschler, O., and M. K. Mueller. 2015. 'Deep enteroscopy - indications, diagnostic yield and 
complications', World J Gastroenterol, 21: 1385-93. 
Neuhaus, H., T. Beyna, M. Schneider, and J. Deviere. 2016. 'Novel motorized spiral enteroscopy: first 
clinical case', VideoGIE, 1: 32-33. 
Prachayakul, V., M. Deesomsak, P. Aswakul, and S. Leelakusolvong. 2013. 'The utility of single-
balloon enteroscopy for the diagnosis and management of small bowel disorders according to 
their clinical manifestations: a retrospective review', BMC Gastroenterol, 13: 103. 
Rondonotti, E., C. Spada, S. Adler, A. May, E. J. Despott, A. Koulaouzidis, S. Panter, D. Domagk, I. 
Fernandez-Urien, G. Rahmi, M. E. Riccioni, J. E. van Hooft, C. Hassan, and M. Pennazio. 
2018. 'Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and 
treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) 
Technical Review', Endoscopy, 50: 423-46. 
Sanaka, M. R., U. Navaneethan, B. Kosuru, H. Yerneni, R. Lopez, and J. J. Vargo. 2012. 'Antegrade is 
more effective than retrograde enteroscopy for evaluation and management of suspected 
small-bowel disease', Clin Gastroenterol Hepatol, 10: 910-6. 
Sethi, S., J. Cohen, A. M. Thaker, S. Garud, M. S. Sawhney, R. Chuttani, D. K. Pleskow, K. Falchuk, 
and T. M. Berzin. 2014. 'Prior capsule endoscopy improves the diagnostic and therapeutic 
yield of single-balloon enteroscopy', Dig Dis Sci, 59: 2497-502. 
Skinner, M., D. Popa, H. Neumann, C. M. Wilcox, and K. Monkemuller. 2014. 'ERCP with the 
overtube-assisted enteroscopy technique: a systematic review', Endoscopy, 46: 560-72. 
 

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16 
STUDY TIMELINE 
Screening period 
May/June 2019 – May/June 2020 
Recruitment period: 
May/June 2019 – May/June 2020 
Database lock 
July 2020 
Data Review Meeting 
July 2020 
Statistical analysis: 
July 2020 
First data available 
August 2020 
Draft report: 
November 2020 
Final CIR 
December 2020 
 
 

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17 
ANNEX 01: DEEP ENTEROSCOPY PROCEDURE 
17.1 General Information 
A lack of frequent stalling of the rotation should be interpretive as a warning to assess the patient 
and scope position. 
Continued rotation without advancement should also be seen as maximum insertion depth. 
The limit function does not guarantee the safety of the procedure. The operator must judge if safe 
insertion can be continued on a case-by-case basis. 
 
17.2 General Insertion tips 
Gentle forward pressure is used when rotation is started as well as throughout the procedure. 
Minimal CO2 insufflation is recommended as small bowel distention will decrease spiral 
advancement. 
Irrigation using a water jet may help with lumen visualization and spiral advancement Intermittent 
external abdominal compression is often helpful to facilitate engagement and advancement of the 
spiral segment. 
17.3 General Withdrawal tips 
Insufflation may be used at will at this time. 
Although the scope may seem to be moving out of the patient quickly, it is important to keep 
holding the scope firmly. 
Slow controlled withdrawal is the key. This is accomplished by backward rotation while 
maintaining the scope position and keeping the tip in motion 
 
 
 
The limit function stops the rotation of the single use PowerSpiral tube when the electric 
current to the motor on the endoscope a setting value. To release, remove your foot from 
the pedal on foot switch. 
The LIMIT Function? 

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17.4 Antegrade Approach 
17.4.1 
Inserting the Scope 
After passage of the bougie, the tip of the scope is advanced through the mouthpiece into 
proximal esophagus. 
 
Rotation is started when the spiral segment is in the proximal pharynx. Begin with slow rotation 
with gentle pressure if needed, and the esophagus is intubated under direct visualization. 
 
 
 
 
 
If significant resistance is encountered during esophageal intubation, the endoscope 
should be removed and the esophagus should be assessed. 
If no stricture is observed or motor stalls frequently, consider passage of a large bougie 
dilator (54-60 Fr) prior to reintroduction of the PowerSpiral. 
A second attempt may be tried, with deflation of endotracheal balloon considered, but if 
stalling continues the procedure image is generated is smaller in caliber than the rotary 
i
l
ti
Note 

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17.4.2 
Passing through the Pharynx & Esophagus 
The spiral segment is engaged in the upper esophageal sphincter and rotational advancement is 
continued using the forward foot switch. 
 
The patient’s neck is extended as needed to straighten the passage through the cervical 
esophagus as the rotating spiral section is less flexible than the remaining section of the scope. 
 
Once the spiral section is past the cervical esophagus, the patient’s neck no longer needs to be 
extended and may be returned to the usual position 
 
 
 
 
 
 
 
 
 
 
 
 
 
Gentle forward pressure is applied while the spiral segment is rotated slowly and 
intermittently using the foot switch facilitating intubation of the esophagus.  
A decrease in the amount of resistance and torque required for advancement is an 
indicator that the cervical esophagus has been passed. 
Note 

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17.4.3 
Passing through the Stomach 
Upon entering the stomach, gastric contents should be aspirated and CO2 insufflation should be 
kept to minimum. 
 
While on the stomach, gentle pushing with rotation of the spiral segment is recommended for 
advancement. 
 
When the insertion tube mark at 80cm is in the mouthpiece, the entire spiral segment is in the 
stomach. 
 
 
 

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17.4.4 
Passing through the Duodenum 
The duodenum and proximal jejunum are fixed. Passage through the segment is accomplished 
with forward rotation and gentle advancement of the scope. 
 
Avoid prolonged rotation when the spiral segment is in the second portion of the duodenum. 
 
Looping should be avoided but can be managed careful withdrawal of the scope along with 
forward rotation of the spiral segment. 
 
Fluoroscopy or ScopeGuide may be useful in assessing looping. 
 
 

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17.4.5 
 Passing through the Small Bowel Distal to the Ligament of Treitz 
Once the spiral segment is positioned in the proximal jejunum, advancement is accomplished 
primarily by rotation of the spiral segment. 
 
Intermittent gentle advancement of the scope in 3-5cm increments when progress seems to slow 
down visually. 
 
Insert as if drawing concentric circles. 
 
 
 

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17.4.6 
 Reaching the Terminal Ileum 
The following images will provide indication of the scope being close to the terminal illeum. 
The ileum becomes apparent with less prominent villi and prominent lymphoid follicles. 
 
The procedure should be terminated if the cecum is encountered. 
 
Do not pass the spiral through the ileo-cecal valve. Stop forward advancement. 
 
 
 

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17.4.7 
 Withdrawal Techniques 
Gentle forward pressure should be maintained to facilitate a slow, controlled withdrawal. This is 
especially true when the duodenum is encountered. 
 
Every effort should be made to be sure the spiral segment is free in the stomach and no longer 
engaged in the duodenum/ pylorus prior to allowing the spiral segment to engage the lower 
esophagus sphincter. This is often accomplished by intermittent use of the forward foot switch to 
confirm disengagement in the stomach. tent use of the forward foot switch to confirm 
disengagement in the stomach. 
 
The PowerSpiral enteroscope has a special marking at 80cm to indicate the spiral segment is 
approaching the lower esophagus sphincter. 
 
 
 

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As the spiral segment encounters the cervical esophagus, the neck is once again extended to 
facilitate atraumatic withdrawal while the spiral segment is rotating. 
 
 
 
 
Increased resistance is an indicator of remaining pleated bowel on the spiral segment. 
This requires advancement of the scope holding position and then resuming backward 
rotation. 
Note 

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17.5 Retrograde Approach 
17.5.1 
Passing through the Colon 
The spiral enteroscope can be passed through the colon with continuous rotation and gentle 
pressure. 
 
Forward rotation of the spiral segment should be used for passage through the anal sphincter. 
 
If lumen cannot be visualized, rotate with caution to advance. 
CO2 insufflation should be minimized and water injection should be considered. 
 
 

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17.5.2 
Eliminating a Loop 
Eliminate a loop by maintaining position of the spiral segment and withdrawing the scope while 
applying forward rotation to the spiral segment. 
Sigmoid Colon: 
 
 
 
 
 
 
 

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Transverse Colon:  
 
 
 
 
 
 
 
 
 The principal is to minimize the amount of scope inserted in the colon thereby preserving 
as much scope length as possible with which to examine the small bowel. This is 
accomplished by minimizing insufflation, and the constant use of withdrawing, torquing, 
shortening, and pleating techniques. 
Tips 

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17.5.3 
Passing through the Ileo-cecal Valve 
The ileocecal valve is intubated using standard colonoscopy techniques. 
 
When passing through the ileocecal valve, insertion can be facilitated by decreasing the angle of 
insertion into the ileum by means of manual compression or postural change. 
 
If insertion into the terminal ileum is still difficult, try retro-flexing the scope inside the cecum and 
inserting the U-shaped distal end of the scope into the ileum with a push-pull technique. 
After passing through the ileocecal valve, advancement is accomplished by rotation of the spiral 
segment and intermittent advancement of the scope through the rectum as well as intermittent 
manual compression to facilitate acquisition of the small bowel on to the insertion tube. 
 
 
 

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17.5.4 
Passing through the Small Bowel 
Once the spiral segment is positioned in the terminal ileum, advancement is accomplished 
primarily by rotation of the spiral segment and intermittent gentle advancement of the scope in 3-
5 cm increments when progress seems to slow down visually. 
 
17.5.5 
Reaching the Proximal Jejunum 
The following images will provide indication of the scope being close to the proximal jejunum. 
The procedure should be terminated if the ampulla or duodenal bulb is encountered. 
 
 
 

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17.5.6 
Withdrawal Techniques 
Slow withdrawal is accomplished with the foot switch in the reverse position and constant 
maneuvering of the scope tip to facilitate gradual and controlled release of the intestine off the tip 
of the scope. 
 
Occasional forward activation of the spiral may be necessary for a slow, controlled withdrawal. 
 
Once the cecum is reached, the scope is withdrawn as in a standardized colonoscopy with or 
without spiral rotation. 
 
 
 

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When the anal sphincter is reached, the passage is accomplished by the spiral rotation in the 
backward direction. 
 
 
Retroflextion should not be performed with the spiral segment in the patient. 
Note