Feasibility of Stereotactic Image Guidance on the Lateral Skull Base
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Quantitative accuracy
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Navigated
Lateral skull base navigation intervention is applied
Intervention: Lateral skull base navigation (Device)
Outcomes
Primary Outcomes
Quantitative accuracy
Time Frame: 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 Outcomes
- Qualitative accuracy(Until the end of the intervention, expected to be up to 4.5 hours)