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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03294213
Recruitment Status : Completed
First Posted : September 26, 2017
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Ambu A/S

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.


Condition or disease Intervention/treatment
Bronchoscopy Anesthesia Device: aScope 4 Broncho

Detailed Description:
Refer to brief description

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Study Type : Observational
Actual Enrollment : 176 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018

Group/Cohort Intervention/treatment
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
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




Primary Outcome Measures :
  1. User perception [ Time Frame: September 2017 to January 2018 ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294213


Locations
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Germany
Klinik für Anästhesiologie, Universitätsmedizin Mainz
Mainz, Rhineland-Palatinate, Germany
Sponsors and Collaborators
Ambu A/S
Investigators
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Study Chair: Pia Nordmand, MSc Ambu A/S
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Responsible Party: Ambu A/S
ClinicalTrials.gov Identifier: NCT03294213    
Other Study ID Numbers: CIS-002
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No