An interventional study of Lateral skull base navigation in Otologic Disease, sponsored by Insel Gruppe AG, University Hospital Bern. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-13.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Treatment
A clinical trial to asses the accuracy, usefulness and usability of a stereotactic image-guidance system during lateral skull base surgery.
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.
48 studies on the registry are indexed under Ear Diseases; 10 are open to participants now.
This study's enrollment of 3 is below the median of 61 across 37 interventional studies indexed under Ear Diseases.
Browse Ear Diseases studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lateral skull base navigation intervention is applied
Device: 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
Quantitative accuracy
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.
Time frame: Until the end of the intervention, expected to be up to 4.5 hours
Qualitative accuracy
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.
Time frame: Until the end of the intervention, expected to be up to 4.5 hours
Plan to share: No
Ran from Jan 2020 to primary completion in Dec 2020, 11 months.
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This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern →