Capsule Sponge Study in Eosinophilic Oesophagitis
NCT Number: NCT06501274
Acronym: Cosie
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Eosinophilic Esophagitis
Interventions: DEVICE: capsule sponge
Sponsor: East and North Hertfordshire NHS Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-07-31
Completion Date: 2025-07-31
Locations: East and North Herts NHS Trust, Stevenage, Hertfordshire, SG1 4AB, United Kingdom

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.

Primary Outcome Measures: • 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, through study completion, an average of 1 year|• symptom score, Dysphagia symptom score (DSQ) scored as continuous variable in 2 weeks prior to capsule sponge, through study completion, an average of 1 year|• Eosinophil count on cytology, no of eosinophils per high powered field on cytology, through study completion, an average of 1 year|• Patient pain evaluation, wong -baker faces visual scale from 0 to 10 with 0 being no pain and 10 being maximum pain, through study completion, an average of 1 year|patient preference for endoscopy or capsule sponge, tick box, through study completion, an average of 1 year
Secondary Outcome Measures: • Failure to swallow rate, proportion of patients unable to swallow device after 2 attempts, through study completion, an average of 1 year|• Inadequate sample rate, proportion of samples with inadequate squamous cells for analysis, through study completion, an average of 1 year|• Complications, recognised immediate complications, through study completion, an average of 1 year|• Repeat gastroscopy rate, numbers of patients requiring gastroscopy within 1year of sponge, through study completion, an average of 1 year|Cost evaluation, comparison of sponge v gastroscopy real world costs of service in GB Pounds, at end of study at 2 years