NCT01669278

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 20, 2012

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

First QC Date

August 7, 2012

Last Update Submit

September 14, 2016

Conditions

Otorhinolaryngologic Diseases

Keywords

sheathflexibleendoscopyotolaryngologyoffice

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Physician and staff satisfaction

    1 week

  • Optical quality

    1 hour

Study Arms (2)

Traditional flexible nasopharyngolaryngoscopy

NO INTERVENTION

No sheath procedure

Sheath flexible nasopharyngolaryngoscopy

ACTIVE COMPARATOR

Flexible nasopharyngolaryngoscopy using endosheath

Device: Endosheath

Interventions

EndosheathDEVICE

Flexible sheathed nasopharyngolaryngoscopy

Sheath flexible nasopharyngolaryngoscopy

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6H 2H7, Canada

Location

MeSH Terms

Conditions

Otorhinolaryngologic Diseases

Study Officials

  • Dr. Allan Ho

    University of Alberta

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2012

First Posted

August 20, 2012

Last Updated

September 16, 2016

Record last verified: 2016-09

Locations

CA(1)