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A Feasibility Study of a Modular Video Augmentation System for Image-Guided Skull Base Surgery

NCT ID: NCT01591954

Last Updated: 2016-12-01

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-01-31

Brief Summary

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Current standard of care for complex head, neck and skull base surgery require navigation systems that allow instruments to be tracked optically or electromagnetically while registered to a patient's pre-operative X-ray computed tomography (CT) or magnetic resonance image (MRI). However, conventionally, the CT/MRI data is not registered with video endoscopy. Augmentation of endoscopic video by preoperative data can facilitate navigation around critical structures and robust target resection. The work presented here describes evaluation of a high definition (HD) video-overlay system for endonasal endoscopic skull base surgery. We adopt a modular design that can be extended for other video augmentation applications. The system supports fast automatic camera calibration, comparable in re-projection errors to standard camera calibration tools, while performing within appropriate run time for clinical use. Phantom studies have shown the registration accuracy of the system to be equivalent to that of conventional optical tracking. With this system we are proposing a clinical pilot study in a small number of patients at Johns Hopkins Hospital to evaluate basic feasibility and to gather qualitative assessment of the video augmentation system.

Detailed Description

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Conditions

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Feasibility of Video Augmentation System Value of Video Augmentation Navigation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Video Augmentation

Qualitative assessment of the value of video-based navigation system

Group Type EXPERIMENTAL

Video Augmentation

Intervention Type DEVICE

Assessment of value of video-based navigation system

Interventions

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Video Augmentation

Assessment of value of video-based navigation system

Intervention Type DEVICE

Other Intervention Names

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Interfaces with Medtronic Stealthstation

Eligibility Criteria

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Inclusion Criteria

* Participants must be at least 18 years of age or older;
* Have an existing clinically ordered CT image within 2 weeks of the study; or
* Have an existing clinically ordered MR image within 2 weeks of the study;
* Provide written informed consent after receiving a verbal and written explanation of the purpose and nature of this clinical study;
* Be able to communicate effectively with clinical study personnel

Exclusion Criteria

* Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of the procedure;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gary L Gallia, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Hospital Department of Neurosurgery

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00051786

Identifier Type: OTHER

Identifier Source: secondary_id

J11101

Identifier Type: -

Identifier Source: org_study_id