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

Primary Purpose

Otologic Disease

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Lateral skull base navigation
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otologic Disease focused on measuring Image-guidance, Lateral skull base surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Inselspital University hospital of Bern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Navigated

Arm Description

Lateral skull base navigation intervention is applied

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 19, 2019
Last Updated
February 9, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT03852329
Brief Title
Feasibility of Stereotactic Image Guidance on the Lateral Skull Base
Acronym
LSBN
Official Title
Feasibility of Stereotactic Image Guidance on the Lateral Skull Base
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment due to Pandemic
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otologic Disease
Keywords
Image-guidance, Lateral skull base surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, single-arm, non-controlled
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Navigated
Arm Type
Experimental
Arm Description
Lateral skull base navigation intervention is applied
Intervention Type
Device
Intervention Name(s)
Lateral skull base navigation
Intervention Description
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 Measure Information:
Title
Quantitative accuracy
Description
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
Secondary Outcome Measure Information:
Title
Qualitative accuracy
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Caversaccio, Prof.
Organizational Affiliation
Inselspital university hospital of Bern
Official's Role
Study Chair
Facility Information:
Facility Name
Inselspital University hospital of Bern
City
Bern
ZIP/Postal Code
3008
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34692764
Citation
Schneider D, Anschuetz L, Mueller F, Hermann J, O'Toole Bom Braga G, Wagner F, Weder S, Mantokoudis G, Weber S, Caversaccio M. Freehand Stereotactic Image-Guidance Tailored to Neurotologic Surgery. Front Surg. 2021 Oct 7;8:742112. doi: 10.3389/fsurg.2021.742112. eCollection 2021.
Results Reference
derived

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Feasibility of Stereotactic Image Guidance on the Lateral Skull Base

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