DysphagiaNCT01200147
Effectiveness of Rupture of Schatzki's Ring Using Biopsy Forceps Versus SIngle Dilation
A study testing study withdrawn no details in people with Dysphagia and Schatzki Ring, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dysphagia, Schatzki Ring
- What is being tested?
- study withdrawn no details
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Sep 2010
- 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
- Presenting to endoscopy unit with symptoms of dysphagia or known history of schatzki ring
Who cannot join
- Prior esophageal or gastric surgery, severe esophagitis, coagulopathy
Trial locations and contacts
1 site in 1 country.
Canada1 site
VG Hospital-Capital District Health Authority
Halifax, Nova Scotia, B3H2Y9
About this study
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.
Read the detailed description
None available, study was withdrawn
- Conditions
- Dysphagia, Schatzki Ring
- Being tested
- study withdrawn no details
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study withdrawn no detailsOther
| Study group | Role | What they receive |
|---|---|---|
| Study withdrawn no details | No intervention | Not described Receives: Other: study withdrawn no details |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Manufacturer stopped producing rings
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.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark McMillan, MD FRCPC, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200147
- Sponsor's protocol ID
- Schatzki-2010
- Status last verified
- Nov 2022
- First submitted
- 10 Sep 2010
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: study withdrawn, no patients enrolled
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Rupture of Schatzki's Ring Using Biopsy Forceps Versus SIngle Dilation
- ClinicalTrials.gov ID
- NCT01200147
- Acronym / sponsor ID
- Schatzki-2010
- Conditions
- Dysphagia, Schatzki Ring
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Manufacturer stopped producing rings
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 13 Sep 2010 (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.
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.
Detailed description
None available, study was withdrawn
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study withdrawn no details | No intervention | Other: study withdrawn no details |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presenting to endoscopy unit with symptoms of dysphagia or known history of schatzki ring
Key exclusion criteria (1 listed)
- Prior esophageal or gastric surgery, severe esophagitis, coagulopathy
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 |
|---|---|---|
| study withdrawn no details | Other | Study withdrawn no details |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No. study withdrawn, no patients enrolled
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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.
Mark McMillan, MD FRCPC principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing study withdrawn no details in people with Dysphagia and Schatzki Ring, run by Nova Scotia Health Authority at 1 site in Canada.
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: withdrawn, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was withdrawn before enrolling participants, so there are no results.
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.
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 8 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.