BronchoscopyNCT03294213

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

An observational study of Bronchoscopy and Anesthesia, run by Ambu A/S at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Bronchoscopy, Anesthesia
What is being tested?: aScope 4 Broncho
Type of treatment: Medical device
How many people: 176 participants
Where: 1 siteGermany
Study dates: 25 Sep 2017to 31 Jan 2018
Phase: Observational
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 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Germany1 site

Klinik für Anästhesiologie, Universitätsmedizin Mainz
Mainz, Rhineland-Palatinate

Other trials in Germany

About this study

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.

Read the detailed description

Refer to brief description

Conditions: Bronchoscopy, Anesthesia
Being tested: aScope 4 Broncho

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

aScope 4 BronchoDevice
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

Study groups in NCT03294213
Study group	Role	What they receive
aScope 4 Broncho		The only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho Receives: Device: aScope 4 Broncho

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Data on patients from September 2017 to January 2018, investigators memory assessed immediately following use of the aSCope 4TM Broncho at each patient visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 201731 Jan 2018

First posted26 Sep 2017
Study start25 Sep 2017
Primary completion31 Jan 2018
Study completion31 Jan 2018

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 BronchoscopyStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03294213
Sponsor's protocol ID: CIS-002
Status last verified: Feb 2021
First submitted: 22 Sep 2017
Last updated: 3 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bronchoscopy trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView
ClinicalTrials.gov ID: NCT03294213
Acronym / sponsor ID: CIS-002
Conditions: Bronchoscopy, Anesthesia
Study type: Observational
Recruitment status: Completed
Enrolment: 176 participants (actual)
Lead sponsor: Ambu A/SIndustry (pharma, biotech, devices)
Study start: 25 Sep 2017 (actual)
Primary completion: 31 Jan 2018 (actual)
Study completion: 31 Jan 2018 (actual)
First posted: 26 Sep 2017 (actual)
Results: Posted 3 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is designed as a prospective observational, non-controlled, non-interventional study.

The involved sites will include patients during a five months' period, from September 2017 to January 2018.

Detailed description

Refer to brief description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
aScope 4 Broncho	–	Device: aScope 4 BronchoThe only data to be obtained are evaluation forms directly related to the users' perception of the aScope™ 4 Broncho

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

None

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
aScope 4 BronchoInvestigator 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	Device	aScope 4 Broncho

Primary outcome

User Preference of Scope
Time frame: Data on patients from September 2017 to January 2018, investigators memory assessed immediately following use of the aSCope 4TM Broncho at each patient visit
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.

Results and safety

Results posted to the registry on 3 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
aScope 4 Broncho	176	176

Primary outcome: User Preference of Scope

Time frame: Data on patients from September 2017 to January 2018, investigators memory assessed immediately following use of the aSCope 4TM Broncho at each patient visit. Count of participants. Unit: Participants

Measure	aScope 4 Broncho n = 175
Prefer aScope 4 Broncho	103
Prefer standard bronchoscope	37
No preference on bronchoscope	35

Adverse events

Time frame: Data collected over the course of 5 months, Adverse Events assessed during each procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
aScope 4 Broncho	0 of 176 (0%)	2 of 176 (1.1%)	0 of 176

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Bronchoscopy

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RecruitingObservational study
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Lung Disease, Pneumothorax
Enrolling by invitationPhase 2
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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.

Pia Nordmand, MSc 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?

An observational study of Bronchoscopy and Anesthesia, run by Ambu A/S at 1 site in Germany.

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 3 inclusion and 1 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: finished, as of the sponsor's last update on 3 Mar 2021. 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 Germany. 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 3 Mar 2021). 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?

User Preference of Scope (time frame: Data on patients from September 2017 to January 2018, investigators memory assessed immediately following use of the aSCope 4TM Broncho at each patient visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03294213.

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 3 Mar 2021.