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Feasibility of Stereotactic Image Guidance on the Lateral Skull Base

NCT03852329 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-02-13

No results posted yet for this study

Summary

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

Conditions

  • Otologic Disease

Interventions

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

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Marco Caversaccio, Prof. · Inselspital university hospital of Bern

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03852329 on ClinicalTrials.gov