Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06501274

Capsule Sponge Study in Eosinophilic Oesophagitis

Led by East and North Hertfordshire NHS Trust · Updated on 2024-07-15

140

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Open pragmatic, descriptive single site study in adult patients with non-stenotic eosinophilic oesophagitis. To assess the clinical value of Capsule sponge in the assessment of treatment response in patients with known non-stenosing eosinophilic oesophagitis, as an alternative to gastroscopy in a real world setting. To assess patient preference for Capsule sponge or gastroscopy. All patients with non-stenosing eosinophilic oesophagitis who are reviewed in clinic that have not had reassessment of their oesophagus post treatment initiation or change in treatment will be offered Capsule sponge as an alternative to gastroscopy. A standardised clinical symptom questionnaire will be self-administered for 2w prior to clinic visits and Capsule sponge. Telephone triage for safety check and exclusion criteria by Capsule sponge nurse. A patient symptom questionnaire at the time of procedure by research nurse. A patient satisfaction survey will be delivered after the Capsule sponge procedure by Capsule sponge nurse. Cytological assessment of the Capsule sponge and eosinophil count and other markers of inflammation will be reported by Cyted. Clinic follow up will occur at approximately 6-8 weeks post Capsule sponge. Descriptive Changes in management as a result of the Capsule sponge findings and /or symptoms will be recorded by clinician.

CONDITIONS

Official Title

Capsule Sponge Study in Eosinophilic Oesophagitis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with non-stenotic eosinophilic oesophagitis who have a change in treatment
Not Eligible

You will not qualify if you...

  • Strictures or rings at most recent endoscopy that prevent passage of adult gastroscope
  • Previous oesophageal dilatation
  • Previous oesophageal perforation or surgical resection
  • Oesophago-gastric malignancy
  • Oesophageal varices
  • Bolus obstruction since last endoscopy requiring hospital visit
  • Previous fundoplication or complicated hiatus hernia
  • Patient on Warfarin with INR>=3
  • Suspected new diagnosis of EOE without prior endoscopic confirmation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

East and North Herts NHS Trust

Stevenage, Hertfordshire, United Kingdom, SG1 4AB

Actively Recruiting

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Research Team

T

Toral Odedra

CONTACT

T

Toral Odedra

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Capsule Sponge Study in Eosinophilic Oesophagitis | DecenTrialz