Endoscopical Dilation of Benign Esophageal Strictures

November 29, 2012 updated by: Bengt Wallner, University Hospital, Umeå

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A
Dilation 10 sec
Device: Dilation 10 sec
Other Names:
  • CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd
ACTIVE_COMPARATOR: Group B
Dilation 2 min
Device: Dilation 2 min
Other Names:
  • CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relief from dysphagia
Time Frame: 1 year from dilation
1 year from dilation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Umeå

Collaborators

Uppsala University
Boston Scientific Corporation

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 Major Dates

Study Start

December 1, 2003

Primary Completion (ACTUAL)

December 1, 2006

Study Registration Dates

First Submitted

November 28, 2012

First Submitted That Met QC Criteria

November 29, 2012

First Posted (ESTIMATE)

November 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 30, 2012

Last Update Submitted That Met QC Criteria

November 29, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 02-499

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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