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

NCT03294213 | Completed Results

• 1 other identifier: CIS-002
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bronchoscopy; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

aScope 4 Broncho

The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho

Device: aScope 4 Broncho

Interventions

aScope 4 Broncho DEVICE

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

aScope 4 Broncho

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Ambu A/S: lead

Study Sites (1)

Klinik für Anästhesiologie, Universitätsmedizin Mainz

Mainz, Rhineland-Palatinate, Germany

Location

Results Point of Contact

• Title: Anna Lundgaard
• Organization: Ambu A/S

aclu@ambu.com

+4529643748

Study Officials

• Pia Nordmand, MSc

  Ambu A/S

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 26, 2017
• Study Start: September 25, 2017
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: March 3, 2021
• Results First Posted: March 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)