- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01181362
Comparing Head and Neck Endoscopy Procedures
May 28, 2013 updated by: University Health Network, Toronto
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- University Health Network, Princess Margaret Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
August 12, 2010
First Submitted That Met QC Criteria
August 12, 2010
First Posted (Estimate)
August 13, 2010
Study Record Updates
Last Update Posted (Estimate)
May 29, 2013
Last Update Submitted That Met QC Criteria
May 28, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UHN REB 09-0886-AE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Comparing Head And Neck Endoscopy in Healthy Patients
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University of California, IrvineWithdrawnAnesthetized Healthy Patients (ASA 1 or 2) in the Supine Position, Excluding Head, Neck and Head Surgeries | Anesthetized Patient With Severe Systemic Disease (ASA 3 or 4)United States
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L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio...Consorzio Mario Negri SudWithdrawnPredictable BTP at Swallowing in in Head/Neck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background PainItaly
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National Taiwan University HospitalUnknownHead and Neck Cancers PatientsTaiwan
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University of WashingtonGuerbetWithdrawnMalignant Neoplasm in the Head and Neck | Metastatic Malignant Neoplasm in the Head and NeckUnited States
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Tel-Aviv Sourasky Medical CenterUnknownHead and Neck Cancer Patients Treated With Radiotherapy
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Assistance Publique Hopitaux De MarseilleCompletedPatients With Head and Neck Cancer (ORL)France
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