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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

Locations
Other Locations
United Kingdom
East and North Herts NHS Trust
RECRUITING
Stevenage
Contact Information
Primary
Toral Odedra
toral.odedra@nhs.net
01438 314333
Backup
Toral Odedra
toral.odedra@nhs.net
Time Frame
Start Date: 2023-07-31
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 140
Treatments
Other: all eligible patients with non stenotic eosinophilic oesophagitis
single arm observational study
Sponsors
Leads: East and North Hertfordshire NHS Trust

This content was sourced from clinicaltrials.gov