- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00583960
Office-based Radial Expansion Balloon Dilation of the Esophagus and Trachea
June 9, 2015 updated by: University of California, Davis
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.
Study Overview
Status
Withdrawn
Conditions
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
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
UCDMC Otolaryngology Voice and Swallowing Center patients
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Belafsky, MD, PhD, University of California, Davis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
December 26, 2007
First Submitted That Met QC Criteria
December 26, 2007
First Posted (Estimate)
January 2, 2008
Study Record Updates
Last Update Posted (Estimate)
June 11, 2015
Last Update Submitted That Met QC Criteria
June 9, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200715177-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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