NCT01200147

Brief 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. 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

Same day

First QC Date

September 10, 2010

Last Update Submit

November 4, 2022

Conditions

Study Arms (1)

Study withdrawn no details

NO INTERVENTION
Other: study withdrawn no details

Interventions

Study withdrawn no details

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presenting to endoscopy unit with symptoms of dysphagia or known history of schatzki ring

You may not qualify if:

  • Prior esophageal or gastric surgery, severe esophagitis, coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VG Hospital-Capital District Health Authority

Halifax, Nova Scotia, B3H2Y9, Canada

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Mark McMillan, MD FRCPC

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2010

First Posted

September 13, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

study withdrawn, no patients enrolled

Locations