Evaluation of BAL Procedure With Ambu aScope 3 Large in Patients in an ICU Setting

NCT03581474 | Terminated Results FDA Device

• 1 other identifier: CIS-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atelectasis; Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

aScope 3 Large

OTHER

Bronchoscopic procedure

Device: Bronchoscopic procedure

Interventions

Bronchoscopic procedure DEVICE

Single-use flexible bronchoscope aScope 3 Large

aScope 3 Large

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ambu A/S: lead

Study Sites (1)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Results Point of Contact

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

aclu@ambu.com

+4529643748

Study Officials

• Anna Charlotte Lundgaard

  Ambu A/S

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: July 10, 2018
• Study Start: September 28, 2017
• Primary Completion: July 3, 2018
• Study Completion: July 3, 2018
• Last Updated: February 13, 2020
• Results First Posted: February 13, 2020

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)