RecruitingNot ApplicableNCT06501274

Capsule Sponge Study in Eosinophilic Oesophagitis

A Pragmatic Interventional Study to Assess the Clinical Value of Capsule Sponge in the Assessment of Response to Treatment of Non-stenotic Eosinophilic Oesophagitis in a Single District General Hospital


Sponsor

East and North Hertfordshire NHS Trust

Enrollment

140 participants

Start Date

Jul 31, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • patients diagnosed with non -stenotic eosinophilic oesophagitis who have a change in treatment

Exclusion Criteria9

  • 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

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Interventions

DEVICEcapsule sponge

capsule sponge sampling device of the oesophagus


Locations(1)

East and North Herts NHS Trust

Stevenage, Hertfordshire, United Kingdom

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NCT06501274


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