Office-Based Radial Expansion Balloon Dilation of the Esophagus and Trachea - Full Text View

Sponsored by:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00583960

Purpose

Retrospective chart review of UCDMC patients who have undergone esophageal or tracheal balloon dilation to record data including age, gender, diagnosis pre-and post-procedure eating assessment tool, esophagoscopy findings, tracheobronchoscopy findings, and pre-and post-procedure videofluoroscopic findings.

Condition
Tracheal Stenosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Retrospective
Official Title:	Office-Based Radial Expansion Balloon Dilation of the Esophagus and Trachea

Further study details as provided by University of California, Davis:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	March 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Detailed Description:

Dilation of the esophagus is performed for strictures, webs, and rings at all levels of the esophagus. Dilation of the trachea is performed for subglottic and tracheal stenosis. Radial expansion balloons have been developed by Bost Scientific Corporation for the purpose of dilating the esophagus and trachea through flexible esophagoscopies. These sequential controlled radial-expansion balloons can be introduced via a guide wire through the working channel of a 5.1 mm transnasal esophagoscope. Traditionally, otolaryngologists have performed esophageal and tracheal dilation per oral under general anesthesia. This technique allows the procedure to be performed in the office, sparing the patient the risk of anesthetics. The purpose of this study is to review the UCDMC experience with esophageal and tracheal balloon dilation using the transnasal esophagoscope.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

UCDMC Otolaryngology Voice and Swallowing Center patients

Criteria

Inclusion Criteria:

patients who have undergone esophageal or tracheal balloon dilation since 1/1/05
patients who underwent an attempted dilation since 1/1/05

Exclusion Criteria:

Younger than 18 years of age
Those who do not meet the inclusion criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583960

Locations

United States, California
Univeristy of California Davis Medical Center
Sacramento, California, United States, 95817

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator:

Peter Belafsky, MD, PhD

University of California, Davis

More Information

Responsible Party:	University of California Davis ( Peter Belafsky, MD, Ph.D. )
Study ID Numbers:	200715177-1
Study First Received:	December 26, 2007
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00583960
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

swallowing problems
tracheal stenosis

Study placed in the following topic categories:

Respiratory Tract Diseases
Dilatation, Pathologic
Tracheal Stenosis
Constriction, Pathologic

Additional relevant MeSH terms:

Tracheal Diseases

ClinicalTrials.gov processed this record on January 16, 2009