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Observational Study Group for Esophageal Dilation
N/A
Waitlist Available
Led By Magnus Halland, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial found that compared to endoscopy as needed, esophageal self-dilation therapy decreases the number of endoscopic dilations and prolongs the dysphagia-free interval. It is a safe and well-tolerated therapy that significantly lowers the health cost in managing refractory esophageal stricture.
Eligible Conditions
- Esophageal Dilation
- Benign Esophageal Stricture
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Endoscopic Interventions
Secondary outcome measures
Clinically Significant Adverse Events
Length of Days Intervention Free
Mayo Dysphagia Questionnaire (MDQ-30) at 12 Months
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Standard Clinical Care Endoscopic Dilation, Then ESDTExperimental Treatment2 Interventions
Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.
Group II: Observational Study GroupExperimental Treatment2 Interventions
Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.
Group III: Standard Clinical Care Endoscopic Dilation GroupActive Control1 Intervention
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.
Group IV: Esophageal Self-Dilation Therapy (ESDT) GroupActive Control1 Intervention
Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Esophageal self-dilation therapy
2018
N/A
~30
Endoscopic therapy with esophageal dilation
2018
N/A
~30
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,057 Total Patients Enrolled
Magnus Halland, M.D.Principal InvestigatorMayo Clinic
Jeffrey Alexander, MDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
128 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open enrollments currently available for this medical trial?
"According to clinicaltrials.gov, this investigation is not currently open for recruitment having last been updated on January 10th of 2022. However, 251 other trials remain actively recruiting patients at this time."
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