NCT00372918

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

June 5, 2008

Status Verified

June 1, 2008

Enrollment Period

1.6 years

First QC Date

September 5, 2006

Last Update Submit

June 4, 2008

Conditions

Larynx Disease

Outcome Measures

Primary Outcomes (2)

  • The intraobserver variability of Transnasal Esophagoscopy

    one week apart

  • The interdisciplinary variability of Transnasal Esophagoscopy

    one week apaart

Study Arms (1)

1

OTHER

Transnasal Esophagoscopy

Procedure: Transnasal Esophagoscopy

Interventions

Transnasal EsophagoscopyPROCEDURE

fiberoptic exam of esophagus thru nares

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt ENT Clinic

Nashville, Tennessee, 37232-5280, United States

Location

MeSH Terms

Conditions

Laryngeal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Michael F Vaezi, MD PhD MS

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 5, 2006

First Posted

September 7, 2006

Study Start

September 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

June 5, 2008

Record last verified: 2008-06

Locations

US(1)