MedTrace Logo

Capsule Sponge Study in Eosinophilic Oesophagitis

NCT06501274 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2024-07-15

No results posted yet for this study

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.

Conditions

  • Eosinophilic Esophagitis

Interventions

DEVICE

capsule sponge

capsule sponge sampling device of the oesophagus

Sponsors & Collaborators

  • East and North Hertfordshire NHS Trust

    lead OTHER_GOV

Principal Investigators

  • Danielle Morris, MD FRCP · East and North Herts NHS Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-31
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06501274 on ClinicalTrials.gov