Otologic DiseaseLSBNNCT03852329
Feasibility of Stereotactic Image Guidance on the Lateral Skull Base
A study testing Lateral skull base navigation in people with Otologic Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
A clinical trial to asses the accuracy, usefulness and usability of a stereotactic image-guidance system during lateral skull base surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Otologic Disease
- What is being tested?
- Lateral skull base navigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients which are regularly scheduled for an otologic surgical procedure
- Informed Consent as documented by signature
- Age >= 18 years
Who cannot join
- Other clinically condition or disease that would (as deemed by the operating surgeon) significantly increase the risk of surgery
Trial locations and contacts
1 site in 1 country.
About this study
A clinical trial to asses the accuracy, usefulness and usability of a stereotactic image-guidance system during lateral skull base surgery.
Read the 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.
- Conditions
- Otologic Disease
- Being tested
- Lateral skull base navigation
- Keywords
- Image-guidance, Lateral skull base surgery
- Medical subject headings
- Ear Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral skull base navigationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Navigated | Experimental | Lateral skull base navigation intervention is applied Receives: Device: Lateral skull base navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until the end of the intervention, expected to be up to 4.5 hours
Secondary outcomes (1)
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.
Measured: Until the end of the intervention, expected to be up to 4.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Jan 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: Insufficient recruitment due to Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Otologic DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-arm, non-controlled
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Caversaccio, Prof., Study chair, Inselspital university hospital of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852329
- Sponsor's protocol ID
- 0001-0001
- Acronym
- LSBN
- Status last verified
- Feb 2023
- First submitted
- 19 Feb 2019
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34692764
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Stereotactic Image Guidance on the Lateral Skull Base
- ClinicalTrials.gov ID
- NCT03852329
- Acronym / sponsor ID
- LSBN / 0001-0001
- Conditions
- Otologic Disease
- Keywords
- Image-guidance, Lateral skull base surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment due to Pandemic
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm, non-controlled
| Arm | Type | Receives |
|---|---|---|
| Navigated | Experimental | Device: Lateral skull base navigationLateral skull base navigation intervention is applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients which are regularly scheduled for an otologic surgical procedure
- Informed Consent as documented by signature
- Age >= 18 years
Key exclusion criteria (1 listed)
- Other clinically condition or disease that would (as deemed by the operating surgeon) significantly increase the risk of surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lateral skull base navigationPatient 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 | Device | Navigated |
Primary outcome
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.
1 secondary outcome
Qualitative accuracy
Time frame: Until the end of the intervention, expected to be up to 4.5 hours
Results and safety
The study was stopped early (reason given: Insufficient recruitment due to Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Derived from this study: PubMed 34692764Schneider 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Caversaccio, Prof. study chair
Inselspital university hospital of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral skull base navigation in people with Otologic Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment due to Pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative accuracy (time frame: Until the end of the intervention, expected to be up to 4.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03852329, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.