DysphagiaNCT01738997
Endoscopical Dilation of Benign Esophageal Strictures
A study testing Dilation 10 sec and Dilation 2 min in people with Dysphagia, run by University Hospital, Umeå.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dysphagia
- What is being tested?
- Dilation 10 sec and Dilation 2 min
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic dysphagia with an endoscopic picture suggestive of a benign disease
Who cannot join
- Suspicion of achalasia or malignancy. If the patients needed more than 3 dilations the first month this was also a considered an exclusion criterion
About this study
Official title: 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
- Conditions
- Dysphagia
- Being tested
- Dilation 10 sec, Dilation 2 min
- Keywords
- Benign, Esophageal strictures, Esophagus, Balloon Dilation
- Medical subject headings
- Deglutition Disorders, Esophageal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dilation 10 secDevice
Also called CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd
Dilation 2 minDevice
Also called CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Dilation 10 sec Receives: Device: Dilation 10 sec |
| Group B | Active comparator | Dilation 2 min Receives: Device: Dilation 2 min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief from dysphagia
Measured: 1 year from dilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startDec 2003
- Primary completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Umeå
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University, Boston Scientific Corporation
- Responsible party
- Principal investigator, Bengt Wallner, University Hospital, Umeå
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738997
- Sponsor's protocol ID
- Dnr 02-499
- Status last verified
- Nov 2012
- First submitted
- 28 Nov 2012
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopical Dilation of Benign Esophageal Strictures - a Randomized, Clinical Trial, Comparing Two Different Inflation Times.
- ClinicalTrials.gov ID
- NCT01738997
- Acronym / sponsor ID
- Dnr 02-499
- Conditions
- Dysphagia
- Keywords
- Benign, Esophageal strictures, Esophagus, Balloon Dilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, UmeåUniversity, hospital or other
- Collaborators
- Uppsala University, Boston Scientific Corporation
- Study start
- Dec 2003
- Primary completion
- Dec 2006 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Dilation 10 secDilation 10 sec |
| Group B | Active comparator | Device: Dilation 2 minDilation 2 min |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic dysphagia with an endoscopic picture suggestive of a benign disease
Key exclusion criteria (1 listed)
- Suspicion of achalasia or malignancy. If the patients needed more than 3 dilations the first month this was also a considered an exclusion criterion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dilation 10 secAlso: CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd | Device | Group A |
| Dilation 2 minAlso: CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd | Device | Group B |
Primary outcome
Relief from dysphagia
Time frame: 1 year from dilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dilation 10 sec and Dilation 2 min in people with Dysphagia, run by University Hospital, Umeå.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief from dysphagia (time frame: 1 year from dilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2012.