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Endoscopical Dilation of Benign Esophageal Strictures

This study has been completed.
Sponsor:
Collaborators:
Uppsala University
Boston Scientific Corporation
Information provided by (Responsible Party):
Bengt Wallner, University Hospital, Umeå
ClinicalTrials.gov Identifier:
NCT01738997
First received: November 28, 2012
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention
Dysphagia
Device: Dilation 10 sec
Device: Dilation 2 min

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopical Dilation of Benign Esophageal Strictures - a Randomized, Clinical Trial, Comparing Two Different Inflation Times.

Resource links provided by NLM:


Further study details as provided by University Hospital, Umeå:

Primary Outcome Measures:
  • Relief from dysphagia [ Time Frame: 1 year from dilation ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2003
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Dilation 10 sec
Device: Dilation 10 sec
Other Name: CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd
Active Comparator: Group B
Dilation 2 min
Device: Dilation 2 min
Other Name: CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Bengt Wallner, MD, PhD, University Hospital, Umeå
ClinicalTrials.gov Identifier: NCT01738997     History of Changes
Other Study ID Numbers: Dnr 02-499
Study First Received: November 28, 2012
Last Updated: November 29, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Umeå:
Benign
Esophageal strictures
Esophagus
Balloon Dilation

Additional relevant MeSH terms:
Esophageal Stenosis
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014