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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03294213
Other study ID # CIS-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 25, 2017
Est. completion date January 31, 2018

Study information

Verified date February 2021
Source Ambu A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is designed as a prospective observational, non-controlled, non-interventional study. 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. The study will include a minimum of 100 adult patients admitted to the operating room (OR) or Intensive Care Unit (ICU) undergoing at least one bronchoscopy procedure. The inclusion will stop when 100 fully evaluable patients or a maximum of 150 patients have been enrolled. The involved sites will include patients during a five months' period, from September 2017 to January 2018.


Description:

Refer to brief description


Recruitment information / eligibility

Status Completed
Enrollment 176
Est. completion date January 31, 2018
Est. primary completion date January 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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

Locations

Country Name City State
Germany Klinik für Anästhesiologie, Universitätsmedizin Mainz Mainz Rhineland-Palatinate

Sponsors (1)

Lead Sponsor Collaborator
Ambu A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary User Preference of Scope 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. Data on patients from September 2017 to January 2018, investigators memory assessed immediately following use of the aSCope 4TM Broncho at each patient visit
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