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


N/A
18 Years
N/A
Open (Enrolling)
Both
Feasibility of Video Augmentation System, Value of Video Augmentation Navigation

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Trial Information

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


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;

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Qualitative Assessment of Video Augmentation Software by Post-operative Survey of Neurosurgeon and Otolaryngologist

Outcome Description:

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.

Outcome Time Frame:

Assessment is immediate, following operation.

Safety Issue:

Yes

Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins Hospital Department of Neurosurgery

Authority:

United States: Food and Drug Administration

Study ID:

J11101

NCT ID:

NCT01591954

Start Date:

January 2012

Completion Date:

December 2012

Related Keywords:

  • Feasibility of Video Augmentation System
  • Value of Video Augmentation Navigation

Name

Location

Johns Hopkins HospitalBaltimore, Maryland  21287