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Office-based Radial Expansion Balloon Dilation of the Esophagus and Trachea

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ClinicalTrials.gov Identifier: NCT00583960
Recruitment Status : Withdrawn (PI chose not to proceed with study.)
First Posted : January 2, 2008
Last Update Posted : June 11, 2015
Sponsor:
Information provided by:
University of California, Davis

Brief Summary:
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 or disease
Tracheal Stenosis

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.

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Office-based Radial Expansion Balloon Dilation of the Esophagus and Trachea

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00583960


Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Peter Belafsky, MD, PhD University of California, Davis

Responsible Party: Peter Belafsky, MD, Ph.D., University of California Davis
ClinicalTrials.gov Identifier: NCT00583960     History of Changes
Other Study ID Numbers: 200715177-1
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015

Keywords provided by University of California, Davis:
swallowing problems
tracheal stenosis

Additional relevant MeSH terms:
Tracheal Stenosis
Tracheal Diseases
Respiratory Tract Diseases