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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03852329
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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

Condition or disease Intervention/treatment Phase
Otologic Disease Device: Lateral skull base navigation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, single-arm, non-controlled
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Stereotactic Image Guidance on the Lateral Skull Base
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Navigated
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





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Qualitative accuracy [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852329


Contacts
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Contact: Marco Caversaccio, Prof. +41 31 632 29 21 marco.caversaccio@insel.ch
Contact: Stefan Weber, Prof. +41 31 632 75 74 stefan.weber@artorg.unibe.ch

Locations
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Switzerland
Inselspital University hospital of Bern Recruiting
Bern, Switzerland, 3008
Contact: Marco Caversaccio, Prof.    +41 31 632 29 21    marco.caversaccio@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Study Chair: Marco Caversaccio, Prof. Inselspital university hospital of Bern
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03852329    
Other Study ID Numbers: 0001-0001
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
Image-guidance
Lateral skull base surgery
Additional relevant MeSH terms:
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Ear Diseases
Otorhinolaryngologic Diseases