AtelectasisNCT03581474
Evaluation of BAL Procedure With Ambu aScope 3 Large in Patients in an ICU Setting
A study testing Bronchoscopic procedure in people with Atelectasis and Bronchoscopy, run by Ambu A/S at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atelectasis, Bronchoscopy
- What is being tested?
- Bronchoscopic procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2017to 3 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medicine
Chicago, Illinois, 60637
About this study
Official title: Evaluation of a Bronchoalveolar Lavage Procedure With a Flexible Disposable Bronchoscope, Ambu aScope 3 Large in Patients in an Intensive Care Unit Setting
An Investigation to determine the single-use scope's ability to suction secretion from the lungs to resolve the collapse of the lung.
Read the detailed 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.
- Conditions
- Atelectasis, Bronchoscopy
- Being tested
- Bronchoscopic procedure
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopic procedureDevice
Single-use flexible bronchoscope aScope 3 Large
| Study group | Role | What they receive |
|---|---|---|
| aScope 3 Large | Other | Bronchoscopic procedure Receives: Device: Bronchoscopic procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start28 Sep 2017
- Primary completion3 Jul 2018
- Study completion3 Jul 2018
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ambu A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Charlotte Lundgaard, Study chair, Ambu A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581474
- Sponsor's protocol ID
- CIS-001
- Status last verified
- Jun 2018
- First submitted
- 22 Sep 2017
- Last updated
- 13 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Bronchoalveolar Lavage Procedure With a Flexible Disposable Bronchoscope, Ambu aScope 3 Large in Patients in an Intensive Care Unit Setting
- ClinicalTrials.gov ID
- NCT03581474
- Acronym / sponsor ID
- CIS-001
- Conditions
- Atelectasis, Bronchoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ambu A/SIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 3 Jul 2018 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Posted 13 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Investigation to determine the single-use scope's ability to suction secretion from the lungs to resolve the collapse of the lung.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aScope 3 Large | Other | Device: Bronchoscopic procedureBronchoscopic procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoscopic procedureSingle-use flexible bronchoscope aScope 3 Large | Device | aScope 3 Large |
Primary outcome
Improvement in Oxygenation (PaO2/FiO2 Ratio) After a BAL Treatment
Time frame: 4 hours after procedure
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Charlotte Lundgaard study chair
Ambu A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopic procedure in people with Atelectasis and Bronchoscopy, run by Ambu A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Oxygenation (PaO2/FiO2 Ratio) After a BAL Treatment (time frame: 4 hours after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.