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Device
Short Duration 6Fed Sponge For EoE Patients
N/A
Waitlist Available
Led By Karthik Ravi
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 2 years
Awards & highlights
No Placebo-Only Group
Summary
This research is being done to see if the investigators can use the cytosponge or esophacap (depending on availability) to determine if shorter duration SFED (two weeks versus six weeks) would have equal results.
Eligible Conditions
- Eosinophilic Esophagitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cytosponge pathology: number of Eosinophils directing dietary therapy
Secondary study objectives
Eosinophilic Esophgitis Activity Index Pro (EEsAI Pro)
The tolerability of esophageal sponge compared to upper endoscopy with biopsy.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cytosponge, Diet, EEsAI Pro, Likert Scoring ScaleExperimental Treatment4 Interventions
Patients going through the six food elimination diet (clinically) for EoE will be asked to participate. During the initial 6 week elimination period, participants will return at 2, 4 and 6 weeks to swallow the cytosponge. The cytosponge is a 10 minute procedure done in the office. This will be sent for histology, \<15 phf would be considered a responder. Results of the histology will help the investigator to direct the future of the 6 food elimination diet to determine if a period of 6 weeks of initial elimination is necessary. The EEsAI Pro questionnaire measures symptomatic response to the elimination of the foods. The Likert Scoring Scale measures patient experience of the cytosponge and the upper endoscopy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytosponge
2014
N/A
~190
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,066,006 Total Patients Enrolled
25 Trials studying Eosinophilic Esophagitis
1,491 Patients Enrolled for Eosinophilic Esophagitis
Karthik RaviPrincipal InvestigatorMayo Clinic