CompletedNCT01738997Updated Nov 30, 2012

Endoscopical Dilation of Benign Esophageal Strictures

An interventional study of Dilation 10 sec and Dilation 2 min in Dysphagia, sponsored by University Hospital, Umeå. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-11-30.

Sponsored by University Hospital, Umeå · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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

Conditions studied

Dysphagia

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Keywords

Benign
Esophageal strictures
Esophagus
Balloon Dilation

In context

Esophageal Stenosis

50 studies on the registry are indexed under Esophageal Stenosis; 11 are open to participants now.

This study's enrollment of 20 is below the median of 24 across 41 interventional studies indexed under Esophageal Stenosis.

Browse Esophageal Stenosis studies →

Lead sponsor

University Hospital, Umeå is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Symptomatic dysphagia with an endoscopic picture suggestive of a benign disease

Exclusion criteria

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

Experimental
Group A
Dilation 10 sec
Device: Dilation 10 sec
Active comparator
Group B
Dilation 2 min
Device: Dilation 2 min

Interventions

DeviceDilation 10 sec
Also known as: CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd
DeviceDilation 2 min
Also known as: CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd

What researchers measure

Primary outcomes

Relief from dysphagia
Time frame: 1 year from dilation

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01738997
Lead sponsor: University Hospital, Umeå
Collaborators: Uppsala University, Boston Scientific Corporation
Responsible party: Bengt Wallner (MD, PhD, University Hospital, Umeå) — Principal investigator
First posted: Nov 30, 2012
Start date: Dec 2003
Primary completion: Dec 2006
Last update: Nov 30, 2012

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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