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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This study has been withdrawn prior to enrollment.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

December 26, 2007
December 16, 2010
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Complete list of historical versions of study NCT00583960 on ClinicalTrials.gov Archive Site
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Office-based Radial Expansion Balloon Dilation of the Esophagus and Trachea
Office-based Radial Expansion Balloon Dilation of the Esophagus and Trachea

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Probability Sample

UCDMC Otolaryngology Voice and Swallowing Center patients

Tracheal Stenosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
50
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00583960
200715177-1
No
Peter Belafsky, MD, Ph.D., University of California Davis
University of California, Davis
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Principal Investigator: Peter Belafsky, MD, PhD University of California, Davis
University of California, Davis
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP