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

This study has been withdrawn prior to enrollment.
(PI chose not to proceed with study.)
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00583960
First received: December 26, 2007
Last updated: December 16, 2010
Last verified: December 2010
  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

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

Resource links provided by NLM:


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

Estimated Enrollment: 50
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Peter Belafsky, MD, Ph.D., University of California Davis
ClinicalTrials.gov Identifier: NCT00583960     History of Changes
Other Study ID Numbers: 200715177-1
Study First Received: December 26, 2007
Last Updated: December 16, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Constriction, Pathologic
Tracheal Stenosis
Pathological Conditions, Anatomical
Tracheal Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 23, 2014