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

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

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.

Study Overview

• Status: Terminated
• Conditions: Feasibility of Video Augmentation System; Value of Video Augmentation Navigation
• Intervention / Treatment: Device: Video Augmentation

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video Augmentation; Qualitative assessment of the value of video-based navigation system	Device: Video Augmentation; Assessment of value of video-based navigation system; Other Names: Interfaces with Medtronic Stealthstation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative Assessment of Video Augmentation Software by Post-operative Survey of Neurosurgeon and Otolaryngologist	The qualitative assessment of new video augmentation software by the three surgeons surveys the effect of video augmentation overlay on overall surgical confidence, procedure, approach, and visualization.; = Significant hindrance / Negative effect;; = Minor hindrance / Slightly negative effect;; = Not helpful / No benefit or hindrance;; = Somewhat helpful / Slight benefit;; = Very helpful / Major benefit. Evaluation of safety is determined by collecting data regarding additional time, personnel and possible contamination.	Assessment is immediate, following operation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data Recording for Retrospective Analysis	The secondary outcome variable of this study is the data recorded by the video augmentation system during pertinent portions of the operation. We will be targeting steps in the procedure that would have the greatest benefit from an augmented video scene to be used later for further studies. Such data will form the subject of retrospective analysis of workflow. Three sets of data will be collected to be able to reconstruct the video scene for analysis of the system: - Tracked Endoscope information.; - Video from endoscopy; - Planning CT/MRI data	Data is recorded during case.

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Investigators: Principal Investigator: Gary L Gallia, M.D., Ph.D., Johns Hopkins Hospital Department of Neurosurgery

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: May 1, 2012
• First Submitted That Met QC Criteria: May 2, 2012
• First Posted (Estimate): May 4, 2012

Study Record Updates

• Last Update Posted (Estimate): December 1, 2016
• Last Update Submitted That Met QC Criteria: October 7, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: J11101; NA_00051786 (Other Identifier: JHMIRB)