Chest
BronchoscopyNovel Flexible Bronchoscope and Single-Use Disposable-Sheath Endoscope System: A Preliminary Technology Evaluation
Section snippets
Study Protocol
The protocol for this study was written and executed by the authors at the request of the manufacturer. The manufacturer did not dictate study design or participate in results analysis. The primary aim of this study was to measure overall performance of the medical device. No comparisons with preexisting instruments were attempted. The study was approved by the Institutional Review Board at each study site.
The three study sites were chosen by the manufacturer. The investigators at each of the
Results
Twenty-four patients at three institutions participated in this study. None of the procedures were terminated prematurely because of instrument malfunction, although an operator switched to a conventional bronchoscope on one occasion. Bronchoscopists in two of the participating institutions noted that the conversion of the fiberoptic-derived image was not always ideal when a video camera was placed onto the head of the bronchoscope using a standard C mount. It was also occasionally difficult to
Discussion
The results of this preliminary evaluation demonstrate the acceptable optics and handling profile of this novel system. We believe this justifies consideration for its introduction into general bronchoscopic practice, particularly since the system has been approved by the US Food and Drug Administration, and similar systems are already being used for flexible sigmoidoscopy10 and nasopharyngeal laryngoscopy.11
Current technology does not allow incorporation of a distal charge-coupled device into
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Cited by (0)
This work was supported in part by Vision Sciences, Natick, MA, who provided the investigators with a Vision Sciences B-F 100 flexible fiberoptic bronchoscope, BS-F21 EndoSheath bronchoscope barriers, and technical support as needed at no cost throughout the duration of the study.