Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView
Conditions: Bronchoscopy, Anesthesia
Sponsor: Ambu A/S

Protocol – Non-interventional study 
1/10 
Product Name: 
aScope™ 4 Broncho and aView 
 
Rev. 2 
 
CIS-002 Prospective Non-interventional Evaluation 
of Intubation and Intensive Care Use of the New 
aScope™ 4 Broncho and aView 
 
 
NCT03294213 
 
 
Protocol: 08.sep.2017 
Amendment on sample size: 25oct2017 
 
 

Protocol – Non-interventional study 
2/10 
Product Name: 
aScope™ 4 Broncho and aView 
 
Rev. 2 
 
1. 
INTRODUCTION 
Flexible bronchoscopy is a valuable tool in the evaluation and management of the upper airway 
and bronchial tree in patients undergoing procedures in the operating room (OR) or in the 
critically ill patients in the intensive care unit (ICU).  
The CE-marked aScope™ 4 Broncho is used for intubation procedures in non-difficult and 
difficult airways, percutaneous tracheotomy, placing double lumen tubes, bronchial blockers, in 
performing bronchoscopy procedures such as inspection of the bronchial tree, bronchial wash 
(BW), broncho alveolar lavage (BAL), secretion management, and the use of tools (e.g. a 
microbiology brush) in the ICU and the OR. 1,2,3 
 
This non-interventional evaluation will focus on the use of Ambu® aScope™ 4 Broncho System 
for the therapeutic use and clinical practice at the discretion of the treating physician, both in 
the OR and ICU.  
Non-interventional Studies are currently not regulated for medical devices, however the 
principles laid out in the Council Directive 93/42 EEC of 14 June 1993 and amendment 
2007/47/EC4, ISO 141555, and the Helsinki Declaration6 was followed. 
2. 
AIM  
The aim of this study is to obtain a broad user perspective of the aScope™ 4 Broncho, focusing 
on the device functionalities within regular clinical practice and therapeutic use of flexible 
bronchoscopes in the OR and ICU. 
3. 
HYPOTHESIS 
The hypothesis is that aScope™ 4 Broncho will be preferred compared to the standard 
methods (i.e. reusable or single-use bronchoscopes) available at the involved sites.  
4. 
END POINT 
All endpoints are qualitative assessments based on the actual use of aScope™ 4 Broncho 
during this study, or the investigators memory of use of their standard bronchoscopes. 
Primary end-point:  
➢ Preference, based on the investigators memory of their standard bronchoscope 
o 
The investigator will be asked: “In your memory, compare your daily 
bronchoscope and the aScope 4 Broncho just evaluated; 
Which bronchoscope would you prefer for this procedure?” 
Secondary end-points: 
➢ Ease of Navigation and Advancement within the bronchial tree with or without 
endoscopic tools (on a 5 grade scale: Very Difficult, Difficult, Acceptable, Easy, Very 
Easy and compared to memory Much better, Slightly better, No difference, Slightly 
worse, Much worse) 

Protocol – Non-interventional study 
3/10 
Product Name: 
aScope™ 4 Broncho and aView 
 
Rev. 2 
 
➢ Ease of Manoeuvrability within the upper airway (on a 5 grade scale: Very Difficult, 
Difficult, Acceptable, Easy, Very Easy and compared to memory Much better, Slightly 
better, No difference, Slightly worse, Much worse) 
➢ Manoeuvrability with tools in the working channel (on a 5 grade scale: Very Poor, Poor, 
Acceptable, Good, Very Good) 
➢ Perception of Image quality channel (on a 5 grade scale: Very Poor, Poor, Acceptable, 
Good, Very Good and compared to memory Much better, Slightly better, No difference, 
Slightly worse, Much worse) 
➢ Perception of Ergonomics (on a 5 grade scale: Very Poor, Poor, Acceptable, Good, Very 
Good and compared to memory Much better, Slightly better, No difference, Slightly 
worse, Much worse) 
➢ Perception of Suction capability (on a 5 grade scale: Very Poor, Poor, Acceptable, Good, 
Very Good and compared to memory Much better, Slightly better, No difference, 
Slightly worse, Much worse) 
➢ Overall perception of functionality (on a 5 grade scale: Very Poor, Poor, Acceptable, 
Good, Very Good) 
➢ Potential to replace exiting standard bronchoscope (Yes, No)  
➢ Adverse events and device deficiencies  
5. 
DESIGN OF INVESTIGATION 
5.1 
Design of investigation 
This study is designed as a prospective observational, non-controlled, non-interventional 
study, with an investigation period lasting for one day (one bronchoscopy procedure). 
 
The study will include a minimum of 100 (amended to 175) adult patients admitted to the OR 
or ICU undergoing at least one bronchoscopy procedure. 
 
The involved sites will include patients during a three months’ period, from September 2017 to 
January 2018. However, the study will not be initiated before the study protocol is duly 
approved, i.e. by local ethics committee if relevant. If the number of patients cannot be 
included in time, the sponsor will decide whether another study site should be added, or if the 
study should be closed. 
 
Only patients who can be clinically evaluated as eligible for a bronchoscopy procedure i.e.  
complies with the listed inclusion and exclusion criteria may be included in the investigation. 
 
The intention of the investigation is to perform subjective quality assessments of the aScope™ 
4 Broncho during bronchoscopy procedures. Patients will not be asked to consent to participate 
in this study, as no patient data are obtained and the CE-marked aScope™ 4 Broncho is used 
within its intended use. The only data to be obtained are evaluation forms directly related to 
the users’ perception of the aScope™ 4 Broncho.  
The Evaluation Forms must be completed for each patient after the clinical procedure is 
finalised.   

Protocol – Non-interventional study 
4/10 
Product Name: 
aScope™ 4 Broncho and aView 
 
Rev. 2 
 
No interventional actions are intended to the patient, other than those already prescribed by 
the investigator and covered by normal clinical procedure consent. 
 
5.2 
Sample size 
The study will include a minimum of 100 (amended to 175) adult patients admitted to the OR 
or ICU undergoing at least one bronchoscopy procedure. 
 
The inclusion will stop when 100 (amended to 175) fully evaluable patients or a maximum of 
150 (amended to 200) patients have been enrolled. 
 
The aim is for each site to enroll a minimum of 10 patients.   
5.3 
Expected time schedule 
First patient in: As soon as reasonably possible after the Ethics Committee approval (if 
relevant), expected in September 2017 
 
Last patient out: Three months after the first subject has been enrolled into the study, 
expected in January 2018 
5.4 
Randomisation  
There is no concurrent control in the study and hence randomisation is not applicable.   
6. 
TEST PARTICIPANTS 
6.1 
Inclusion criteria 
• 
Patient’s ≥18 years 
• 
Clinical indication and eligible for an airway procedure involving a bronchoscopy 
procedure, as judged by the Investigator  
• 
Patients being admitted in the OR or ICU at the investigational site  
6.2 
Exclusion criteria 
• 
None 
6.3 
Recruitment 
The patients included in this investigation will be under treatment in the OR or ICU 
department, and clinically judged by the Investigator to be eligible for a bronchoscopy 
procedure such as tracheal intubation, broncho-alveolar lavage or biopsy, etc. The decision on 
which available bronchoscope to prescribe during the clinical procedure fully lies with the 
investigator. If aScope™ 4 Broncho is chosen, the evaluation form should be completed after 
finalising the clinical procedure.  
The investigator assures that the patient meets all inclusion criteria and none of the exclusion 
criteria, by checking the relevant boxes in the evaluation form. 

Protocol – Non-interventional study 
5/10 
Product Name: 
aScope™ 4 Broncho and aView 
 
Rev. 2 
 
The patient will not receive information about the study, as no patient data are obtained, and 
since the CE-marked aScope™ 4 Broncho is used within its intended use. The only data to be 
obtained are evaluation forms directly related to the users’ perception of the aScope™ 4 
Broncho.  
 
6.4 
Exclusion during the examination 
No patients will be excluded during an examination as the patients are following normal clinical 
procedures as judged by their physician. 
Due to the study being a qualitative assessment of the aScope™ 4 Broncho, the patients shall 
be excluded from data analysis if: 
 
• 
The patient fail to comply with the inclusion and exclusion criteria 
7. 
PROCEDURE 
During normal clinical procedures within the OR or ICU where a bronchoscopy is requested, the 
investigator shall decide which bronchoscope (type/model) should be used for the 
patient/procedure as soon as possible. If the aScope™ 4 Broncho is chosen the provided 
evaluation form should be completed after finalising the clinical procedure. As the study follows 
everyday clinical procedures at the selected sites, the patients will adult patients admitted to 
the OR or ICU, undergoing at least one bronchoscopy procedure.  
8. 
MATERIALS 
8.1 
Device description 
8.1.1 
General information and device description 
Ambu® aScope™ 4 Broncho is produced by Ambu A/S, (Baltorpbakken 13, 2750 Ballerup 
Denmark), and is a sterile single use bronchoscope intended to be used with the Ambu® 
aView™ monitor, endotherapy accessories and other ancillary equipment for endoscopy within 
the airways and tracheobronchial tree.  
 
Ambu® aScope™ 4 Broncho size Slim, Regular and Large, and the Ambu® aView™ monitor are 
all CE-marked, and thereby approved for sale in Europe. 
 
All aScope™ materials that are in contact with the patient, have been tested for 
biocompatibility with reference to ISO 10993, current version. 
 
During the study the participating sites will utilize the following single use Ambu® aScope™ 4 
Broncho.   
 
SPECIFICATIONS 
aScope 4 Slim 
(3.8/1.2) 
aScope 4 Regular 
(5.0/2.2) 
aScope 4 Large 
(5.8/2.8) 
Optical System 
Field of View 
85˚ 
85˚ 
85˚ 
Depth of Field 
6-50 mm 
6-50 mm 
6-50 mm 
Illumination method 
LED 
LED 
LED 
Insertion Portion 
Bending section 
180˚ up, 180˚ down 
180˚ up, 180˚ down 
180˚ up, 160˚ down 
Insertion cord diameter 
3.8 mm 
5.0 mm 
5.8 mm 

Protocol – Non-interventional study 
6/10 
Product Name: 
aScope™ 4 Broncho and aView 
 
Rev. 2 
 
Distal end diameter 
4.2 mm 
5.4 mm 
6.2 mm 
Max. diameter of insertion 
portion 
4.3 mm 
5.5 mm 
6.3 mm 
Min. endotracheal tube 
size (ID)  
5.0 mm 
6.0 mm 
7.0 mm 
Min. double lumen tube 
size (ID)  
37 Fr 
41 Fr 
NA 
Working length 
600 mm 
600 mm 
600 mm 
Channel 
Min. instrument channel 
width 
1.2 mm 
2.0 mm 
2.6 mm 
Suction performance 
(water) 
~0.1 l/min 
~0.7 l/min 
~1.2 l/min 
Table 1: General characteristics and specifications for the aScope4 family. 
 
SPECIFICATIONS 
aView 
Display  
Max. resolution 
800*480 
Orientation 
Landscape 
Display type 
8.5’’, color TFT, LCD 
Electrical power 
Power requirement 
18V 1.674 DC input 
Battery type 
10.8V 4300mAh 
Dimensions  
Width 
241mm (9.49”) 
Height 
175mm (6.89”) 
Thickness 
33,5mm (1,32”) 
Weight 
1500g (331lbs) 
Table 2: General characteristics and specifications for the aView (aScope4 family). 
 
8.1.2 
Precaution and handling 
 
The system must not be used if, in the opinion of a qualified physician, such an application 
would endanger the patient or if the system as such or the method is contraindicated. Such 
cases will not be considered as part of the study. 
 
The Ambu® aScope™ 4 Broncho system must be handled according to the Instructions for use 
(IFU). 
 
8.2 
Investigator’s Brochure 
As the devices are approved for sale (CE-marked), an Investigator’s Brochure is not required. 
The IFU will be available in the packaging of the devices.   
8.3 
Device Accountability and Traceability 
The sites included in the study will free of charge receive a number of the Ambu® aScope™ 4 
Broncho devices based on their expectation of number of clinical procedures to be performed 
within the study period. For the purpose of the study 1-2 Ambu® aView™ monitors per site will 
be provided as well. Any devices remaining after the end of the study will be accounted for and 
shall be returned to Ambu®. 

Protocol – Non-interventional study 
7/10 
Product Name: 
aScope™ 4 Broncho and aView 
 
Rev. 2 
 
There are no requirements regarding device accountability for CE marked devices. However, 
for logistical reasons the Sponsor will account for all devices delivered to and returned from 
the Investigators in a Device Accountability Form kept at Sponsor’s address.  
9. 
MONITORING 
During the period of the study, a representative of the Sponsor will act as monitor/s of the 
study. The Investigator may contact Sponsor representatives, as listed on page Error! 
Bookmark not defined., at any time.  
9.1 
Monitoring Visits 
• 
Initiation Visit: This meeting will be held before the study is initiated, and the aim of the 
meeting is to ensure that the investigators are well informed about the study procedures, 
perform a page-by-page revision of the protocol and ensure that investigators are trained 
in completing the evaluation form. Moreover, approvals from Ethics Committee will be 
verified, if relevant, and monitoring arrangements will be discussed. It is required that the 
Principal Investigator are present in this meeting.  
• 
Routine monitoring visit: The aim of these monitoring visits is to corroborate the study 
progress. The evaluation form will be monitored for completeness of the data. It is 
required that at least one Investigator is available during monitoring visits.  
• 
Close-out visit: The aim of this meeting is to close financial aspects, check that all 
essential documents are complete, device accountability, collection of the original 
evaluation forms, and notification of the corresponding Ethics Committee, if relevant. This 
meeting will be conducted after the last device have been used or no later than three 
months after initiation of the study.  
The monitor is responsible for planning the monitoring visits. 
9.2 
Source Data Verification 
Not applicable for this study, as no patient data are collected. 
10. 
AUDIT 
Not applicable for this study, refer instead to section Error! Reference source not found.. 
11. 
EVALUATION FORM 
The evaluation form is in English and should be filled in English when possible. Missing data 
not recorded on the day of the procedure should be filled in no later than one week after the 
procedure, accompanied by date and signature. Data that are evaluated as incorrect by 
Investigator should be crossed over with ink allowing the “old data” to be seen (example). The 
Investigator shall then write the new and correct data and then sign and date. 
11.1 
Patient Registration List 
Not applicable for this study, as no patient data are collected. 

Protocol – Non-interventional study 
8/10 
Product Name: 
aScope™ 4 Broncho and aView 
 
Rev. 2 
 
12. 
 
12.1 
Patient Information 
Not applicable for this study, as no patient data are collected. 
12.2 
Informed Consent 
Not applicable for this study, as no patient data are collected. 
13. 
DATA MANAGEMENT AND STATISTICAL ANALYSIS 
13.1 
Sample size 
No sample size calculations have been performed for this study as the data obtained only will 
form basis for increased knowledge of the investigators perception and increase user 
awareness of their available bronchoscopes. 
 
The study will include a minimum of 100 (amended to 175) randomly selected adult patients 
admitted to the OR or ICU undergoing at least one bronchoscopy procedure. 
 
The inclusion will stop when a maximum of 150 (amended to 200) patients have enrolled. 
 
13.2 
Data management 
A database will be set up, and two individuals at Ambu A/S will perform double data entry, or 
alternatively remote data capture through SmartTrial will be used. Any unclear data points will 
be highlighted in a data clarification form that will be sent to the responsible Investigator for 
clarification. An error list will be generated, and errors corrected by Ambu A/S staff. 
Thereafter, data transfer from the Sponsor site to the statistician, StatCons (C/O Mikael 
Åström, Högerudsgatan 8B, SE-216 18 Malmö, Sweden); will be done according to the 
regulation of the Danish law for treatment of personal information.  
13.3 
Statistical analyses 
13.3.1 
General aspects 
Descriptive statistics, i.e. number of procedures, mean, median, standard deviation, minimum 
and maximum values for continuous data and frequencies and percentages for categorical data 
will be presented for primary and secondary endpoints as applicable. All endpoints are 
qualitative assessments based on the actual use of aScope™ 4 Broncho during this study or 
the investigators memory of use of their standard bronchoscopes. 
13.3.2 
Handling of dropouts and missing data 
Patients not completing the clinical procedure as intended by the investigator are considered 
as drop-outs as the evaluation form will lack information of the device. Drop-outs are not 
compensated in the sample size estimation, as the number of drop-outs of intended clinical 
procedures are expected to be limited. In case of higher drop-out than accounted for (5%), it 
is recognized that recruitment may be extended to involve at least the minimum number of 
evaluable evaluation forms. Missing data will not be imputed. 

Protocol – Non-interventional study 
9/10 
Product Name: 
aScope™ 4 Broncho and aView 
 
Rev. 2 
 
13.3.3 
Centre analyses 
This investigation is a multi-centre investigation. However, there is no a priori reason to 
suspect that there will be any qualitative differences between the study sites regarding any of 
the outcome variables in the study. Therefore, primary statistical analysis will not include 
centre in the model but analyses may be stratified by centre as applicable. 
13.3.4 
Analysis sets 
All treated patients will be included in the Safety Analysis Set (SAS). 
All correctly, included patients will be included in the Intention-To-Treat (ITT) analysis set. 
Patients who have been treated according to the protocol without any major deviations will be 
included in the Per Protocol (PP) analysis set. 
The primary efficacy analysis set will be PP. However, it is expected the SAS, ITT and PP 
analysis sets will be identical in this study. 
The primary efficacy objective of the investigation will be analysed using data from patients in 
the PP analysis set as well as using data from patients in the ITT analysis set. The conclusion 
will be based on data from the primary efficacy analysis set and the analysis based on data 
from the other efficacy analysis set will be considered as a sensitivity analysis. 
The secondary efficacy objectives will be analysed using data from the primary efficacy 
analysis set only. 
The analyses of the safety objectives will be based on data from the SAS. 
13.3.5 
Statistical analyses during the course of the study 
No analyses will be conducted during the course of the study. 
13.4 
Pass/fail criteria 
The hypothesis is that aScope™ 4 Broncho will be preferred compared to the standard reusable 
or single-use bronchoscopes available at the involved sites.  
This study is considered passed if a minimum of 60% of the device evaluations show that 
aScope™ 4 Broncho is preferred for the clinical procedure or at least on par based on the 
investigators memory of their use of standard bronchoscopes. 
For the secondary end-points, at least 80% of the evaluations must be at the level of 
acceptable, good/very good or easy/very easy or slightly better/much better/no difference. 
13.5 
Data file 
The Sponsor will file the original evaluation forms for rest of the products’ lifetime + 5 years. 
Moreover, study related documents, e.g. protocol, statistical analysis, report will also be filed.  
14. 
LIST OF REFERENCES 
1.  
Hagberg CA. Benumof and Hagberg’s Airway Management: Third Edition.; 2012. 
doi:10.1016/B978-1-4377-2764-7.00057-9. 
2.  
Collins SR, Blank RS. Fiberoptic Intubation: An Overview and Update. Respir Care. 

Protocol – Non-interventional study 
10/10 
Product Name: 
aScope™ 4 Broncho and aView 
 
Rev. 2 
 
2014;59(6):865 LP-880. http://rc.rcjournal.com/content/59/6/865.abstract. 
3.  
Ernst A. Introduction to Bronchoscopy. Cambridge University Press; 2009. 
4.  
COUNCIL DIRECTIVE 93_42_EEC of 14 June 1993 concerning medical devices amendment 
2007/47/EC. 
5.  
ISO 14155:2011(en), Clinical investigation of medical devices for human subjects — Good clinical 
practice. 
6.  
WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. 
7.  
European Commision. MEDDEV 2.12/1 rev.8 - Guidance document - Market surveillance - 
Guidelines on a Medical Devices Vigilance System. 
http://ec.europa.eu/DocsRoom/documents/15506/attachments/1/translations. Accessed March 8, 
2017. 
8.  
Medical devices - Application of risk management to medical devices (ISO 14971:2007. 2012.