- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01200147
Effectiveness of Rupture of Schatzki's Ring Using Biopsy Forceps Versus SIngle Dilation
November 4, 2022 updated by: Nova Scotia Health Authority
Dysphagia is a common reason for referal to the investigators Gastoenterology service.
As many as 14% of patients undergoing radiological studies for dysphagia are found to have schatzki rings.
Current recommendations for treatment of patients with symptomatic Schatzki rings are based on ancedotal experience and uncontrolled studies.
The only randomized study on comparison of techniques the investigators were able to locate was published in 2000 and included only 26 patients.
This study demonstrated that the biopsy techinque was as effective as and better tolerated than the standard dilation technique.
Considering that the cost and time required for dilatation is greater than the basic biopsy technique, significant cost savings could be achieved using the biopsy technique.
As well, patient satisfaction is an important factor considering that Schatzki rings can recur and repeated endoscopy is often required.
Therefore, a study that shows a technique to be as or better than the current standard in effectiveness, cost, time, and patient comfort could lead to shift in current practice.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
None available, study was withdrawn
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H2Y9
- VG Hospital-Capital District Health Authority
-
-
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:
- Presenting to endoscopy unit with symptoms of dysphagia or known history of schatzki ring
Exclusion Criteria:
- Prior esophageal or gastric surgery, severe esophagitis, coagulopathy
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Study withdrawn no details
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mark McMillan, MD FRCPC, Nova Scotia Health Authority
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
September 1, 2010
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
September 10, 2010
First Submitted That Met QC Criteria
September 10, 2010
First Posted (Estimate)
September 13, 2010
Study Record Updates
Last Update Posted (Actual)
November 8, 2022
Last Update Submitted That Met QC Criteria
November 4, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Schatzki-2010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
study withdrawn, no patients enrolled
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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