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

Purpose To carry out a pilot study to evaluate the efficacy of a novel, drivable endoscope (the Peregrine (TM) 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 degrees, 30 degrees and 70 degrees, 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