Trial Information
A Feasibility Study Comparing Head And Neck Endoscopy Procedures In The Upright And Supine Positions
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
To compare and assess subject comfort and adequacy of endoscope sightlines during an endoscopy procedure in both the upright and supine positions.
Outcome Time Frame:
4 months
Safety Issue:
No
Principal Investigator
John Cho, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Health Network, Princess Margaret Hospital
Authority:
Canada: Review Ethics Committee
Study ID:
UHN REB 09-0886-AE
NCT ID:
NCT01181362
Start Date:
September 2010
Completion Date:
January 2013
Related Keywords:
- Comparing Head And Neck Endoscopy in Healthy Patients
- Endoscopy
- Head and Neck region
- Scope