Feasibility of Stereotactic Image Guidance on the Lateral Skull Base (LSBN)

Insel Gruppe AG, University Hospital Bern

Status: Terminated

Conditions: Otologic Disease

Treatments: Device: Lateral skull base navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT03852329

0001-0001

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Navigated

Experimental group

Description:

Lateral skull base navigation intervention is applied

Treatment:

Device: Lateral skull base navigation