CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 176 enrolled
Drug / intervention
aScope 4 Bronchodevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03294213
NCT03294213N/ACompleted

Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView

Ambu A/S·observational·Posted Sep 26, 2017·Updated Mar 3, 2021

In Brief

An observational study evaluating aScope 4 Broncho for Bronchoscopy and Anesthesia. Completed, enrolled 176 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 26, 2017
Enrollment StartSep 25, 2017
Primary CompletionJan 31, 2018
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 8.8 years ago

Interventions

aScope 4 Bronchodevice

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