Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy

NCT ID: NCT01669278

Last Updated: 2016-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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

Conditions

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Otorhinolaryngologic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Traditional flexible nasopharyngolaryngoscopy

No sheath procedure

Group Type NO_INTERVENTION

No interventions assigned to this group

Sheath flexible nasopharyngolaryngoscopy

Flexible nasopharyngolaryngoscopy using endosheath

Group Type ACTIVE_COMPARATOR

Endosheath

Intervention Type DEVICE

Flexible sheathed nasopharyngolaryngoscopy

Interventions

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Endosheath

Flexible sheathed nasopharyngolaryngoscopy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Allan Ho

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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UA-Endo001

Identifier Type: -

Identifier Source: org_study_id

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