CClinicalTrials.gg
CompletedNCT00372918TNEUpdated Jun 5, 2008

Interpretation of Transnasal Esophagoscopy Findings

A Phase 4 interventional study of Transnasal Esophagoscopy in Larynx Disease, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-06-05.

Sponsored by Vanderbilt University · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
98
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine the prevalence of esophageal pathology in patients with voice disorders. In addition, , the intra- and interdisciplinary variability regarding the identification of esophageal pathology will be analyzed in this study.

Read the detailed description

Throat symptoms are common complaints for many patients. Some symptoms are thought to be attributable to laryngopharyngeal reflux (i.e. the reflux of stomach acid to the level of the larynx). It is unclear what role laryngopharyngeal reflux (LPR) has in producing throat symptoms and its relationship to laryngeal pathology. LPR may be more carefully diagnosed if knowledge could be obtained regarding the presence of esophageal manifestations of reflux of stomach acid. Although LPR may occur in the absence of esophageal manifestations, the presence may make this diagnosis more probable. If so, therapy can be more carefully directed.

Using a flexible endoscope, otolaryngologists perform transnasal flexible laryngoscopy. This requires only topical anesthesia and occurs in the clinic setting. The small caliber transnasal esophagoscope was developed in recent years and is performed in a similar manner. It can provide key information regarding esophageal pathology. This obviates the need for administration of anesthesia (i.e. other than the topical, non-sedating agent). Transnasal flexible laryngoscopy is considered to be the standard of care for evaluation of the larynx. Transnasal esophagoscopy is an extension of this standard of care.

There are a number of studies demonstrating the safety and utility of transnasal esophagoscopy in humans. Typically these studies are composed of retrospectively on a select group of patients. Additionally the TNE findings are reviewed by one medical discipline. This study will be the first prospective analysis of TNE in which the findings will be reviewed in a multidisciplinary manner (i.e. otolaryngologists and gastroenterologist). Also, the population involved will be more general than previous studies, representing a myriad of throat symptoms.

02

Conditions studied

  • Larynx Disease

Browse trials for

03

In context

Laryngeal Diseases

136 studies on the registry are indexed under Laryngeal Diseases; 23 are open to participants now.

This study's enrollment of 98 is above the median of 41 across 111 interventional studies indexed under Laryngeal Diseases.

Browse Laryngeal Diseases studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Study participants include persons 18 years and older
  • Patients presenting to the Vanderbilt Voice Center and complaining of throat symptoms. These include hoarseness, throat clearing/pain/burning, heartburn, globus sensation, and acidic/sour taste.
  • New and return patients will be included.

Exclusion criteria

Exclusion criteria:

  • Participants who are unwilling to undergo the study
  • Patients who have had prior esophagoscopy
  • Those who do not sign the consent
  • Pregnant women.
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
98 participants (actual)

Study arms

  • Other
    1

    Transnasal Esophagoscopy

    Procedure: Transnasal Esophagoscopy

Interventions

  • ProcedureTransnasal Esophagoscopy

    fiberoptic exam of esophagus thru nares

06

What researchers measure

Primary outcomes

  1. The intraobserver variability of Transnasal Esophagoscopy

    Time frame: one week apart

  2. The interdisciplinary variability of Transnasal Esophagoscopy

    Time frame: one week apaart

07

Study locations

1 site
  • Vanderbilt ENT Clinic
    Nashville, Tennessee 37232-5280, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00372918
Lead sponsor
Vanderbilt University
First posted
Sep 7, 2006
Start date
Sep 2006
Primary completion
Apr 2008
Completion
Apr 2008
Last update
Jun 5, 2008

Study contacts

Michael F Vaezi, MD PhD MS
principal investigator · Vanderbilt University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion