Thibaut Van Zele1, Ethan Soudry2,3, Roee Landsberg4, Philippe Gevaert5. 1. Department of Otorhinolaryngology, Ghent University Hospital, C Heymanslaan 10, Entrance 69, 9000, Ghent, Belgium. 2. Rabin Medical Center, Petach Tikva, Israel. 3. Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. 4. Assuta Medical Center, Tel Aviv-Yafo, Israel. 5. Department of Otorhinolaryngology, Ghent University Hospital, C Heymanslaan 10, Entrance 69, 9000, Ghent, Belgium. Philippe.Gevaert@ugent.be.
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.
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.
Authors: Alexander M Choi; Michael J Brenner; Daniel Gorelik; Isaac D Erbele; Matthew G Crowson; Prajoy Kadkade; Masayoshi Takashima; Peter L Santa Maria; Robert S Hong; Austin S Rose; Benjamin T Ostrander; Cyrus C Rabbani; Robert J Morrison; Philip A Weissbrod; Alan D Tate; Joshua J Kain; Ioan A Lina; Scott R Shaffer; Omar G Ahmed Journal: OTO Open Date: 2022-09-23