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

Tracheal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00583960
• Other study ID #: 200715177-1
• Status: Withdrawn
• Phase: N/A
• First received: December 26, 2007
• Last updated: June 9, 2015

Study information

• Verified date: June 2015
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Tracheal Stenosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis