NCT03294213

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 176 (actual)
• Sponsor: Ambu A/S · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Refer to brief description

Conditions

• Bronchoscopy
• Anesthesia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-09-25
• Primary completion: 2018-01-31
• Completion: 2018-01-31
• First posted: 2017-09-26
• Last updated: 2021-03-03
• Results posted: 2021-03-03

Locations

1 site across 1 country: Germany