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NCT01669278 Clinical Trial

Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy

Otorhinolaryngologic Diseases Clinical Trial

Official title:
Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy: A Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01669278
Other study ID # UA-Endo001
Secondary ID
Status Withdrawn
Phase N/A
First received August 7, 2012
Last updated September 14, 2016

Study information
Verified date September 2016
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 17 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

Intervention

Device:
• Endosheath
Flexible sheathed nasopharyngolaryngoscopy

Locations
Country Name City State
Canada University of Alberta Edmonton Alberta

Sponsors (1)
Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient pain and discomfort 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 1 hour No
Secondary Physician and staff satisfaction Physician and support staff satisfaction with easy and efficiency of sheathed scopes. 1 week No
Secondary Optical quality Image quality of flexible endoscopy with or without endosheath. 1 hour No
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