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Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01669278
First Posted: August 20, 2012
Last Update Posted: September 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Alberta
  Purpose
The processing of standard flexible nasopharyngoscopes is a time-consuming and costly process. The goal of this study is to determine the efficiency and cost-effectiveness of sheathed flexible endoscope in an office setting.

Condition Intervention
Otorhinolaryngologic Diseases Device: Endosheath

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy: A Randomized Controlled Trial

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Patient pain and discomfort [ Time Frame: 1 hour ]
    Patient Pain and Discomfort i. Patient's reported level of pain based on International Association for the Study of Pain definitions of pain on a 100-mm Visual Analogue Scale ii. Patient's reported level of discomfort on a 100-mm Visual Analogue Scale


Secondary Outcome Measures:
  • Physician and staff satisfaction [ Time Frame: 1 week ]
    Physician and support staff satisfaction with easy and efficiency of sheathed scopes.

  • Optical quality [ Time Frame: 1 hour ]
    Image quality of flexible endoscopy with or without endosheath.


Enrollment: 0
Arms Assigned Interventions
No Intervention: Traditional flexible nasopharyngolaryngoscopy
No sheath procedure
Active Comparator: Sheath flexible nasopharyngolaryngoscopy
Flexible nasopharyngolaryngoscopy using endosheath
Device: Endosheath
Flexible sheathed nasopharyngolaryngoscopy

Detailed Description:

Methods: Randomized, single-blinded, controlled trial

Setting: Office practice of two academic otolaryngologists at a community hospital.

Primary Outcomes: Patient pain and discomfort, Optical quality

Secondary Outcomes: Physician and nursing staff satisfaction

Cost-analysis

Comparison: No-sheath flexible nasopharyngoscopy versus sheathed flexible nasopharyngoscopy

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients presenting to the Otolaryngology-Head and Neck Surgery service with complaints warranting flexible endoscopy

Exclusion Criteria:

  • Known sinonasal masses or nasal polyposis
  • Unable to complete VAS surveys
  • Significant septal deviation
  • Unable to tolerate in-office flexible nasopharyngoscopy
  • Patients who refuse consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669278


Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6H 2H7
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Dr. Allan Ho University of Alberta
  More Information

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01669278     History of Changes
Other Study ID Numbers: UA-Endo001
First Submitted: August 7, 2012
First Posted: August 20, 2012
Last Update Posted: September 16, 2016
Last Verified: September 2016

Keywords provided by University of Alberta:
sheath
flexible
endoscopy
otolaryngology
office

Additional relevant MeSH terms:
Otorhinolaryngologic Diseases