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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03581474
Other study ID # CIS-001
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 28, 2017
Est. completion date July 3, 2018

Study information

Verified date June 2018
Source Ambu A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

An Investigation to determine the single-use scope's ability to suction secretion from the lungs to resolve the collapse of the lung.


Description:

The purpose of this investigation it to determine the single-use scope's ability to suction secretion from the lungs to resolve the collapse of the lung. The hypothesis is that aScope 3 Large is able to manage the secretion and thereby facilitating the resolution of secretion in the lung.


Recruitment information / eligibility

Status Terminated
Enrollment 12
Est. completion date July 3, 2018
Est. primary completion date July 3, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients =18 years

- Clinical indication and eligible for a BAL procedure, as judged by the investigator

- Patients being admitted in the ICU at the investigational centre

- Provision of signed IC by subject, or subject's legal representative e.g. next of kin

Exclusion Criteria:

- Patients where BAL treatment cannot be clinically justified, judged by the investigator

- ETT >7 mm and =8.5 mm in diameter

- Participating in other interventional clinical investigations or have previously participated in this investigation

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Bronchoscopic procedure
Single-use flexible bronchoscope aScope 3 Large

Locations

Country Name City State
United States University of Chicago Medicine Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Ambu A/S

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in Oxygenation (PaO2/FiO2 Ratio) After a BAL Treatment Resolution of atelectasis measured by improvement in oxygenation after a bronchoscopic procedure (bronchoalveolar lavage treatment). PaO2/FiO2 ratio will be compared between baseline and 4 hourst post the BAL procedure. 4 hours after procedure
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