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NCT02255838 · ClinicalTrials.gov registry record · NA
Evaluation of a Disposable Flexible Bronchoscope, aScope IV
A NA study, sponsored by University of Louisville.
- Terminated
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT02255838: Clinical Trial NA study, sponsored by University of Louisville.
NCT02255838 is a NA study that was terminated before completion, run by University of Louisville. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02255838, a NA study, was terminated before completion, sponsored by University of Louisville.
- TERMINATED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
Flexible bronchoscopes are typically reusable and therefore need high level disinfection to prevent inadvertent spread of microbial pathogens from patient to patient. The process of disinfection is time consuming and expensive. Moreover, a bronchoscope being processed may not be readily available for another patient. One solution to this problem was to use a single use disposable sheath that covers a flexible bronchoscope protecting all surfaces of the bronchoscope.(Colt, Beamis, Harrell, \& Mathur, 2000). Another way to eliminate potential hazards with a reusable bronchoscope is the use of a disposable bronchoscope. Such a disposable bronchoscope has been developed (Ambu aScope, Ambu, Glen Burnie, MD) and has been used successfully for intubations in manikins(Scutt et al., 2011) and patients. (Kristensen \& Fredensborg, 2013; Pujol, López, \& Valero, 2010; Tvede, Kristensen, \& Nyhus-Andreasen, 2012). Further advancement in the imaging and handling of this disposable flexible bronchoscope now allows for the purpose of bronchoscopy and broncho-alveolar lavage in critically ill patients with pulmonary compromise. (FDA approval: 05-11-2013 date) The aim of the study is to compare image clarity, suction capacity, and handling performance of a reusable flexible bronchoscope to the disposable flexible bronchoscope. In addition, the investigators intend to perform a cost analysis.
Primary Outcome
Visualization of the two bronchoscopes was measured by using a qualitative scale from 0 to 10; 0 being classified as "cannot be evaluated" and 10 being assessed as optimal visualization
Interventions
- DEVICE Bronchoscope reusable (Storz 8402 2x)
- DEVICE Bronchoscope disposable (aScope 4)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2015-04-01 |
| Est. Completion | 2020-01-14 |
| Phase | NA |
Why NCT02255838 stopped before completion
NCT02255838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Bronchoscope reusable (Storz 8402 2x) is the first listed.
NCT02255838 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02255838 about?
NCT02255838 is a clinical study titled "Evaluation of a Disposable Flexible Bronchoscope, aScope IV". Flexible bronchoscopes are typically reusable and therefore need high level disinfection to prevent inadvertent spread of microbial pathogens from patient to patient. The process of disinfection is time consuming and expensive. Moreover, a bronchoscope being processed may not be readily available fo...
What is the current status of trial NCT02255838?
This trial is currently terminated. It is a NA study. The enrollment target is 12 participants. The study started on 2015-04-01. Estimated completion is 2020-01-14.
What interventions are being tested in trial NCT02255838?
The interventions under investigation include: Bronchoscope reusable (Storz 8402 2x) (DEVICE), Bronchoscope disposable (aScope 4) (DEVICE).
Who is sponsoring clinical trial NCT02255838?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02255838's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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