Trial Outcomes & Findings for Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView (NCT NCT03294213)

Results Overview

This non-interventional study compared the clinical performance of the Ambu aScope 4TM Bron-cho with the standard bronchoscope (reusable or single-use) normally used at each of the study centers based on the investigators memory of the standard bronchoscope.

Recruitment status

COMPLETED

Target enrollment

176 participants

Primary outcome timeframe

Data on patients from September 2017 to January 2018, investigators memory assessed immediately following use of the aSCope 4TM Broncho at each patient visit

Results posted on

2021-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	aScope 4 Broncho The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho aScope 4 Broncho: Investigator is asked: "In your memory, compare your daily bronchoscope and the aScope 4 Broncho just evaluated" on patients admitted to the OR or ICU undergoing at least one bronchoscopy procedure 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
Overall Study STARTED	176
Overall Study COMPLETED	176
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age Data were not collected

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	aScope 4 Broncho n=176 Participants The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho aScope 4 Broncho: Investigator is asked: "In your memory, compare your daily bronchoscope and the aScope 4 Broncho just evaluated" on patients admitted to the OR or ICU undergoing at least one bronchoscopy procedure 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
Sex: Female, Male Female	0 Participants Sex/Gender data were not collected
Sex: Female, Male Male	0 Participants Sex/Gender data were not collected
Region of Enrollment Germany	60 participants n=176 Participants
Region of Enrollment Denmark	35 participants n=176 Participants
Region of Enrollment Sweden	14 participants n=176 Participants
Region of Enrollment United Kingdom	67 participants n=176 Participants

PRIMARY outcome

Timeframe: Data on patients from September 2017 to January 2018, investigators memory assessed immediately following use of the aSCope 4TM Broncho at each patient visit

This non-interventional study compared the clinical performance of the Ambu aScope 4TM Bron-cho with the standard bronchoscope (reusable or single-use) normally used at each of the study centers based on the investigators memory of the standard bronchoscope.

Outcome measures

Outcome measures
Measure	aScope 4 Broncho n=175 Participants The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho aScope 4 Broncho: Investigator is asked: "In your memory, compare your daily bronchoscope and the aScope 4 Broncho just evaluated" on patients admitted to the OR or ICU undergoing at least one bronchoscopy procedure 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
User Preference of Scope Prefer aScope 4 Broncho	103 Participants
User Preference of Scope Prefer standard bronchoscope	37 Participants
User Preference of Scope No preference on bronchoscope	35 Participants

Adverse Events

aScope 4 Broncho

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	aScope 4 Broncho n=176 participants at risk The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho aScope 4 Broncho: Investigator is asked: "In your memory, compare your daily bronchoscope and the aScope 4 Broncho just evaluated" on patients admitted to the OR or ICU undergoing at least one bronchoscopy procedure 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
Product Issues Poor light	0.57% 1/176 • Data collected over the course of 5 months, Adverse Events assessed during each procedure
Product Issues Freezing image and blackout for 60 seconds	0.57% 1/176 • Data collected over the course of 5 months, Adverse Events assessed during each procedure

Additional Information

Anna Lundgaard

Ambu A/S

Phone: +4529643748

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60