Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01669278

Enrollment

Registered

2012-08-20

Start date

Unknown

Completion date

Unknown

Last updated

2016-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otorhinolaryngologic Diseases

Keywords

sheath, flexible, endoscopy, otolaryngology, office

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.

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

Interventions

DEVICEEndosheath

Flexible sheathed nasopharyngolaryngoscopy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Patient pain and discomfort	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

Measure	Time frame	Description
Optical quality	1 hour	Image quality of flexible endoscopy with or without endosheath.
Physician and staff satisfaction	1 week	Physician and support staff satisfaction with easy and efficiency of sheathed scopes.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026