Feasibility of Stereotactic Image Guidance on the Lateral Skull Base

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Otologic Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, single-arm, non-controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Navigated

Lateral skull base navigation intervention is applied

Group Type EXPERIMENTAL

Lateral skull base navigation

Intervention Type DEVICE

Patient preparation: The participant is prepared for the surgery according to clinical standards.

System setup: The hardware components of the investigational device are set up

Tripod fixation: The tripod with integrated registration fiducials is fixed on the participant's skull.

CBCT imaging: A CBCT image of the participant is acquired

Image processing: The CBCT data is loaded on the navigation platform. The registration fiducials are automatically detected in the image data and relevant anatomy is segmented using an otologic planning software.

Measurements: The navigation software is started, and the fiducial positions and segmentations loaded. The measurements are conducted.

Treatment: The surgery is conducted by the surgeon according to clinical standards

Interventions

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Lateral skull base navigation

Patient preparation: The participant is prepared for the surgery according to clinical standards.

System setup: The hardware components of the investigational device are set up

Tripod fixation: The tripod with integrated registration fiducials is fixed on the participant's skull.

CBCT imaging: A CBCT image of the participant is acquired

Image processing: The CBCT data is loaded on the navigation platform. The registration fiducials are automatically detected in the image data and relevant anatomy is segmented using an otologic planning software.

Measurements: The navigation software is started, and the fiducial positions and segmentations loaded. The measurements are conducted.

Treatment: The surgery is conducted by the surgeon according to clinical standards

Intervention Type DEVICE