Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372918
Status:
COMPLETED
Last Update Posted:
2008-06-05
First Post:
2006-09-05
Brief Title:
Interpretation of Transnasal Esophagoscopy Findings
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
An Interdisciplinary Interpretation of Transnasal Esophagoscopy Findings
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TNE
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
Detailed Description:
Throat symptoms are common complaints for many patients Some symptoms are thought to be attributable to laryngopharyngeal reflux ie 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 ie 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 ie otolaryngologists and gastroenterologist Also the population involved will be more general than previous studies representing a myriad of throat symptoms
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 ie 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 ie otolaryngologists and gastroenterologist Also the population involved will be more general than previous studies representing a myriad of throat symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None