Image-Guided Endoscopic Sinus Surgery with 3D Volumetric Visualization of the Nasal Cavity and Paranasal Sinuses: A Clinical Comparative Study

(1) Background: The purpose of this study was to develop an image-guided endoscopic sinus surgery (IGESS) system, named Medigator(R), based on the leave-one-out registration strategy and three-dimensional (3D) volumetric visualization of the nasal cavity and paranasal sinuses. (2) Methods: A phantom was designed and fabricated using a 3D printer. We then performed a phantom-based accuracy evaluation to validate the performance of the developed registration method. We included 11 patients who underwent IGESS for clinical study to compare the performance of the developed IGESS system with that of a commercialized system. (3) Results: The fiducial registration error (FRE) was 0.14 mm, and the target registration error (TRE) was 0.82 +/- 0.50 mm by the phantom-based evaluation. As a result of the clinical comparative study, the average registration times were 36.04 +/- 4.7 and 89.35 +/- 26.1 s for the developed and commercialized systems, respectively (p < 0.05). The image loading time of the developed system was also shorter than that of the commercialized system (p < 0.05). The average accuracy score of the developed system was not significantly different from that of the commercialized system (p > 0.05). (4) Conclusions: The developed system provided an accurate point-to-point registration method based on the leave-one-out strategy. According to the results of the clinical comparative study, we demonstrated that the developed system showed reliable potential for clinical application.