Endoscopical Dilation of Benign Esophageal Strictures

Dysphagia Clinical Trial

Official title:

Endoscopical Dilation of Benign Esophageal Strictures - a Randomized, Clinical Trial, Comparing Two Different Inflation Times.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01738997
• Other study ID #: Dnr 02-499
• Status: Completed
• Phase: N/A
• First received: November 28, 2012
• Last updated: November 29, 2012
• Start date: December 2003

Study information

• Verified date: November 2012
• Source: University Hospital, Umeå
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

Although balloon dilatation is the primary treatment for benign dysphagia, information about the optimal inflation time is lacking. The aim of the current pilot study was to compare 10 seconds inflation time, with 2 minutes inflation time, regarding the efficacy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Symptomatic dysphagia with an endoscopic picture suggestive of a benign disease

Exclusion Criteria:

• Suspicion of achalasia or malignancy. If the patients needed more than 3 dilations the first month this was also a considered an exclusion criterion

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysphagia
• Esophageal Stenosis

Intervention

Device:
• Dilation 10 sec

• Dilation 2 min

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Umeå	Boston Scientific Corporation, Uppsala University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief from dysphagia		1 year from dilation	No