Feasibility of Stereotactic Image Guidance on the Lateral Skull Base

NCT03852329 | Terminated

• 1 other identifier: 0001-0001
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Image-guidance; Lateral skull base surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  Until the end of the intervention, expected to be up to 4.5 hours

Secondary Outcomes (1)

• Qualitative accuracy

  Until the end of the intervention, expected to be up to 4.5 hours

Study Arms (1)

Navigated

EXPERIMENTAL

Lateral skull base navigation intervention is applied

Device: Lateral skull base navigation

Interventions

Lateral skull base navigation DEVICE

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

Navigated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients which are regularly scheduled for an otologic surgical procedure
• Informed Consent as documented by signature
• Age \>= 18 years

You may not qualify if:

• Other clinically condition or disease that would (as deemed by the operating surgeon) significantly increase the risk of surgery

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital University hospital of Bern

Bern, 3008, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 34692764 DERIVED

MeSH Terms

Conditions

Ear Diseases

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Diseases

Study Officials

• Marco Caversaccio, Prof.

  Inselspital university hospital of Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-arm, non-controlled

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 25, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)