Feasibility of Stereotactic Image Guidance on the Lateral Skull Base

Not Applicable

Terminated

• Conditions: Otologic Disease
• Interventions: Device: Lateral skull base navigation

• Registration Number: NCT03852329
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-25
• Study Start: 2020-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Patients which are regularly scheduled for an otologic surgical procedure
• Informed Consent as documented by signature
• Age >= 18 years

Exclusion Criteria

• Other clinically condition or disease that would (as deemed by the operating surgeon) significantly increase the risk of surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Navigated	Lateral skull base navigation	Lateral skull base navigation intervention is applied

Primary Outcome Measures

Name	Time	Method
Quantitative accuracy	Until the end of the intervention, expected to be up to 4.5 hours	The primary endpoint is the localization accuracy of predefined artificial target positions on the registration tripod measured in millimetres.; The tracked instrument is positioned on the target positions. The Euclidean distance between the location of the instrument in the image data as indicated by the stereotactic image guidance system and to the true location of the target point in the image data is measured. The true location of the target points in the image data is determined by alignment of the 3D model of the tripod (including the known target positions on the tripod) with the image data.

Secondary Outcome Measures

Name	Time	Method
Qualitative accuracy	Until the end of the intervention, expected to be up to 4.5 hours	The main secondary endpoint is the qualitative assessment of the guidance accuracy at anatomical landmarks through user rating.; While the tracked pointer is placed on a landmark, a screenshot of the microscope view is taken. Additionally, the pose of the pointer instrument in the image data indicated by the navigation system is stored. Postoperatively, the alignment of the pointer with the anatomical models compared to the microscope view is rated by multiple surgeons using a questionnaire. A five-level Likert scale (Strongly agree, Agree, Undecided, Disagree, Strongly disagree) is used to measure agreement with statements concerning; * Accuracy: The position indicated in the navigation view is correct at a clinically relevant geometric scale; * Usefulness: The information provided by the navigation view is useful to identify anatomical structures during the surgery; * Usability: The application of the navigation system during the surgical procedure is straightforward.

Trial Locations

Locations (1)

Inselspital University hospital of Bern; 🇨🇭 Bern, Switzerland