About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
capsule sponge
Devicecapsule sponge sampling device of the oesophagus
Treatment groups
Trial outcomes
Primary outcomes
• Descriptive Changes in clinical management of EOE following Capsule sponge assessment
has the results of the capsule sponge resulted in a decision to change treatment drug, or drug dose?-yes/ no response
• symptom score
Dysphagia symptom score (DSQ) scored as continuous variable in 2 weeks prior to capsule sponge
• Eosinophil count on cytology
no of eosinophils per high powered field on cytology
• Patient pain evaluation
wong -baker faces visual scale from 0 to 10 with 0 being no pain and 10 being maximum pain
Secondary outcomes
• Failure to swallow rate
proportion of patients unable to swallow device after 2 attempts
• Inadequate sample rate
proportion of samples with inadequate squamous cells for analysis
• Complications
recognised immediate complications
• Repeat gastroscopy rate
numbers of patients requiring gastroscopy within 1year of sponge
Sponsors and contacts
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