A prospective, feasibility study to evaluate the efficacy and usability of a novel drivable endoscope in patients with chronic rhinosinusitis

Thibaut Van Zele, Ethan Soudry, Roee Landsberg, Philippe Gevaert*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: To carry out a pilot study to evaluate the efficacy of a novel, drivable endoscope (the Peregrine™ Drivable ENT Scope), compared to standard rigid endoscopes in the access, visualization, and irrigation of the paranasal sinus anatomy. Methods: A prospective, multi-center, feasibility study was conducted on seventeen subjects who underwent primary functional endoscopic sinus surgery and were evaluated with the drivable endoscope and standard, rigid endoscopes (0°, 30° and 70°, as applicable). A CT scan was available for image guidance, as needed. The primary efficacy endpoint was the ability to access and visualize sinonasal anatomic landmarks. Secondary endpoints included device usability, as measured by a usability questionnaire given to surgeons postoperatively; the device’s ability to irrigate the sinuses and patient reports of tolerability and pain during postoperative procedures. Results: The drivable endoscope success rate in visualizing all paranasal sinus anatomic landmarks was 55.6% better than the standard rigid endoscopes: 98.3% (178/181) versus 42.7% (76/178); p < 0.001. Surgeons rated scores of over 4 (on a 1–5 scale) for the usability of the drivable endoscope to enter the maxillary, frontal and sphenoid sinuses. The ability to irrigate the sinuses using the drivable endoscope was given a mean score of 4.3, and image quality was given a mean score of 3.4. The three patients evaluated postoperatively reported low pain and high tolerability scores with the drivable endoscope. Conclusions: These preliminary results indicate that the drivable endoscope is effective, easy to use and highly tolerable in sinonasal endoscopy.

Original languageEnglish
Pages (from-to)2499-2505
Number of pages7
JournalEuropean Archives of Oto-Rhino-Laryngology
Volume276
Issue number9
DOIs
StatePublished - 1 Sep 2019

Funding

FundersFunder number
3NT Medical Ltd.

    Keywords

    • Chronic rhinosinusitis
    • Drivable endoscope
    • Functional endoscopic sinus surgery (FESS)
    • Nasal endoscopy
    • Paranasal sinus

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