Comparing Head and Neck Endoscopy Procedures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01181362
First received: August 12, 2010
Last updated: May 28, 2013
Last verified: May 2013

August 12, 2010
May 28, 2013
September 2010
January 2013   (final data collection date for primary outcome measure)
To compare and assess subject comfort and adequacy of endoscope sightlines during an endoscopy procedure in both the upright and supine positions. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01181362 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparing Head and Neck Endoscopy Procedures
A Feasibility Study Comparing Head And Neck Endoscopy Procedures In The Upright And Supine Positions

Intensity Modulated Radiation Therapy planning is based on CT images, with tumour volumes defined on this volumetric information data set. However, target delineation also depends on disease seen endoscopically which may not be visible on CT. We are developing imaging and tracking technology to improve target delineation in Radiation Therapy (RT) planning for head & neck cancer using quantitative registration of 2D endoscopic information with CT data. Diagnostic endoscopy is performed in the upright position. CT images and radiation delivery are obtained with the patient in the supine position. The accuracy of the registration will be improved if performed in the same position to prevent mobile soft tissue structures shifting between the upright and supine positions. Since therapy must be performed in the supine position, we intend to check the feasibility of performing endoscopy in the supine treatment position. We will compare and assess patient comfort and endoscopic sightlines during an endoscopy procedure in both the upright and supine positions.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Comparing Head And Neck Endoscopy in Healthy Patients
Procedure: Endoscopy
All patients will meet the physician at the Head and Neck centre at PMH, where they will have a topical anesthetic (lidocaine endotracheal aerosol, 10 mg/dose) sprayed into both nostrils. After allowing 5-10 minutes to let the anesthetic take effect, they will have an endoscopy procedure using a flexible scope inserted through the nostrils. The procedure will first be performed while patients are sitting up. During the procedure, patients will be asked to rate their discomfort on a 10-point scale. The endoscope will then be removed. After a short rest (15 minutes), the endoscopy procedure will be repeated with patients lying down. They will again be asked to rate their level of discomfort. After another short rest for recovery, they will meet with the physician to discuss both endoscopic procedures and to complete a questionnaire on discomfort, tolerance and acceptability
Endoscopy
Intervention: Procedure: Endoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Between 18-70 years of age.
  • Willing to give informed consent.

Exclusion Criteria:

  • Allergy to topical anesthetic nasal spray (lidocaine).
  • Patients who currently have or have had head and neck cancer.
  • Currently pregnant or lactating; or serious co-morbid illness (e.g., cardiovascular, pulmonary).
  • Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol.
  • Concurrent illness, which prevents the subject from undergoing endoscopy.
  • Disorders of the nasal cavity e.g deviated septum
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01181362
UHN REB 09-0886-AE
Yes
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: John Cho, MD University Health Network, Princess Margaret Hospital
University Health Network, Toronto
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP