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

NCT ID: NCT00583960

Last Updated: 2015-06-11

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL

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.

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.

Conditions

Tracheal Stenosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

University of California Davis

Principal Investigators

Peter Belafsky, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Other Identifiers

200715177-1

Identifier Type: -

Identifier Source: org_study_id