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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 aScopeâ„¢ 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.
Refer to brief description
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aScope 4 Broncho | The only data to be obtained are evaluation forms directly related to the users' perception of the aScopeâ„¢ 4 Broncho |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aScope 4 Broncho | Device | 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 aScopeâ„¢ 4 Broncho is used within its intended use |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Data on patients from September 2017 to January 2018, investigators memory assessed immediately following use of the aSCope 4TM Broncho at each patient visit |
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Inclusion Criteria:
Exclusion Criteria:
- None
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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
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| Name | Affiliation | Role |
|---|---|---|
| Pia Nordmand, MSc | Ambu A/S | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Anästhesiologie, Universitätsmedizin Mainz | Mainz | Rhineland-Palatinate | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | aScope 4 Broncho | The only data to be obtained are evaluation forms directly related to the users' perception of the aScopeâ„¢ 4 Broncho 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 aScopeâ„¢ 4 Broncho is used within its intended use |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | aScope 4 Broncho | The only data to be obtained are evaluation forms directly related to the users' perception of the aScopeâ„¢ 4 Broncho 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 aScopeâ„¢ 4 Broncho is used within its intended use |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age Data were not collected |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Data on patients from September 2017 to January 2018, investigators memory assessed immediately following use of the aSCope 4TM Broncho at each patient visit |
|
Data collected over the course of 5 months, Adverse Events assessed during each procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | aScope 4 Broncho | The only data to be obtained are evaluation forms directly related to the users' perception of the aScopeâ„¢ 4 Broncho 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 aScopeâ„¢ 4 Broncho is used within its intended use |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Poor light | Product Issues | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Lundgaard | Ambu A/S | +4529643748 | aclu@ambu.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2017 | Jan 25, 2021 | Prot_SAP_000.pdf |
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|
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Sex/Gender data were not collected | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 176 |
| 0 |
| 176 |
| 2 |
| 176 |
| Freezing image and blackout for 60 seconds | Product Issues | Systematic Assessment |
|
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