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NCT01591954 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Terminated
Registry status
NA
Development phase
1
Enrollment target

NCT01591954: Clinical Trial NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

NCT01591954 is a NA study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01591954, a NA study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

TERMINATED
Registry status
NA
Development phase
1 participants
Enrollment target

Study Summary

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.

Primary Outcome

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. 1. = Significant hindrance / Negative effect; 2. = Minor hindrance / Slightly negative effect; 3. = Not helpful / No benefit or hindrance; 4. = Somewhat helpful / Slight benefit; 5. = Very helpful / Major benefit. Evaluation of safety is determined by collecting data regarding additional time,

Interventions

  • DEVICE Video Augmentation

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2012-01
Est. Completion 2013-01
Phase NA

Why NCT01591954 stopped before completion

NCT01591954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which Video Augmentation is the first listed.

NCT01591954 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01591954 about?

NCT01591954 is a clinical study titled "A Feasibility Study of a Modular Video Augmentation System for Image-Guided 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, conventiona...

What is the current status of trial NCT01591954?

This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2012-01. Estimated completion is 2013-01.

What interventions are being tested in trial NCT01591954?

The interventions under investigation include: Video Augmentation (DEVICE).

Who is sponsoring clinical trial NCT01591954?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01591954's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01591954, the US trial registry maintained by the National Library of Medicine. NCT01591954 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.