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Endoscopical Dilation of Benign Esophageal Strictures

NCT ID: NCT01738997

Last Updated: 2012-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Dysphagia

Keywords

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Benign Esophageal strictures Esophagus Balloon Dilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Dilation 10 sec

Group Type EXPERIMENTAL

Dilation 10 sec

Intervention Type DEVICE

Group B

Dilation 2 min

Group Type ACTIVE_COMPARATOR

Dilation 2 min

Intervention Type DEVICE

Interventions

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Dilation 10 sec

Intervention Type DEVICE

Dilation 2 min

Intervention Type DEVICE

Other Intervention Names

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CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

University Hospital, Umeå

OTHER

Sponsor Role lead

Responsible Party

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Bengt Wallner

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Dnr 02-499

Identifier Type: -

Identifier Source: org_study_id