Clinical trial NCT03852329: Feasibility of Stereotactic Image Guidance on the Lateral Skull Base
Official title: Feasibility of Stereotactic Image Guidance on the Lateral Skull Base
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Otologic Disease
Keywords: Image-guidance
Lateral skull base surgery
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single-arm, non-controlled
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quantitative accuracy
timeFrame: Until the end of the intervention, expected to be up to 4.5 hours
Secondary outcomes:
measure: Qualitative accuracy
timeFrame: Until the end of the intervention, expected to be up to 4.5 hours
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital University hospital of Bern
Study officials:
affiliation: Inselspital university hospital of Bern
name: Marco Caversaccio, Prof.
role: STUDY_CHAIR
References:
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.