Feasibility of Stereotactic Image Guidance on the Lateral Skull Base — LSBN  

Otologic Disease Clinical Trial

Official title: Feasibility of Stereotactic Image Guidance on the Lateral Skull Base

Status Terminated

Clinical Trial Summary

A clinical trial to asses the accuracy, usefulness and usability of a stereotactic image-guidance system during lateral skull base surgery.

Clinical Trial Description

Stereotactic image guidance aims to provide for accurate and precise instrument localization in patient-specific image data. Image guidance is effectively used in various surgical domains such as neurosurgery, nose-surgery and orthopaedic surgery with benefits for patients such as less invasiveness and reduced surgery time. Its application for lateral skull base surgery was proposed and is considered an unmet clinical need. However, the small geometric scale (~0.5 mm) of the anatomical structures within the lateral skull base prevents the effective application of commercially available systems due to their insufficient guidance accuracy. Within the context of robotic cochlear implantation, stereotactic image guidance technology with a guidance accuracy <0.5 mm was developed. The aim of this study is to apply the developed technology in lateral skull base surgery other than robotic cochlear implantation.

This study primarily seeks to determine the effective end-to-end image guidance accuracy of the investigational device at predefined artificial landmarks on a task-specific registration device attached to the skull.

The main secondary objective is to qualitatively assess the available accuracy at predefined anatomical landmarks by visual inspection through surgeons in the absence of quantifiable ground truth information. ;

Related Conditions & MeSH terms

• Ear Diseases
• Otologic Disease

• NCT number: NCT03852329
• Study type: Interventional
• Source: University Hospital Inselspital, Berne
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2020
• Completion date: December 31, 2020