Tokyo, Nov. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059767) titled 'A single-center pilot study to evaluate an assistant-cooperative augmented reality (AR) surgical guidance method in ear, nose and throat (ENT) surgery' on Nov. 13.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Active

Primary Sponsor: Institute - Institute Of Science Tokyo

Condition: Condition - Cholesteatoma otitis media, chronic otitis media, severe sensorineural hearing loss, facial nerve palsy, Meniere's disease, chronic sinusitis, external auditory canal carcinoma Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to evaluate the feasibility and usefulness of a three-dimensional (3D) information presentation system in which a surgical assistant operates a head-mounted display to provide augmented-reality (AR)-based support to the operating surgeon during otologic and rhinologic procedures. Specifically, we will build an environment that enables intuitive intraoperative manipulation and referencing of patient-specific 3D models generated from computed tomography (CT). Through evaluation in both off-the-job training and actual surgical use, we will clarify its practical utility in the clinical setting as well as its educational impact. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Among consented patients who are randomized to the AR-supported arm, the following support will be provided. In the operating room, a display mirroring the head-mounted display (HMD) field of view will be placed next to the microscope/exoscope/endoscope monitor so that the operating surgeon can view it. During surgery, the assistant will wear the HMD and, using its pass-through function, manipulate the patient-specific 3D model while observing the operative field. The operating surgeon will not wear an HMD and will instead view the assistant-operated feed on the display. To maintain sterility, the assistant will perform manipulations outside the sterile field as needed. AR support will include 3D reconstruction of the operative field, changes to the viewing angle of anatomical structures, distance measurements, and reconstruction/planning simulations. Use of conventional two-dimensional CT images will remain available and will not be restricted in the AR-supported arm. Interventions/Control_2 - Among consented patients randomized to the conventional-care arm, surgery will be performed according to standard practice on the basis of information from CT images (and other routine imaging, as applicable) viewed with the institutionally adopted image viewer. No AR support will be used.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients who require surgical treatment for cholesteatoma, chronic otitis media, facial nerve palsy, severe hearing loss, Meniere's disease, external auditory canal carcinoma, or chronic rhinosinusitis and who provide informed consent. Key exclusion criteria - Individuals who cannot personally provide informed consent. Individuals with impaired capacity to make an independent decision about participation, or minors (<20 years of age). Any other individuals deemed unsuitable for participation by the principal investigator or co-investigators. Target Size - 110

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 29 Day Anticipated trial start date - 2025 Year 11 Month 12 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068141

Disclaimer: Curated by HT Syndication.