NCT06501274 Capsule Sponge Study in Eosinophilic Oesophagitis
| NCT ID | NCT06501274 |
| Status | Recruiting |
| Phase | — |
| Sponsor | East and North Hertfordshire NHS Trust |
| Condition | Eosinophilic Esophagitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2023-07-31 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2023-07-31 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: • patients diagnosed with non -stenotic eosinophilic oesophagitis who have a change in treatment Exclusion Criteria: * 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
Contact & Investigator
Danielle Morris, MD FRCP
PRINCIPAL INVESTIGATOR
East and North Herts NHS Trust
Frequently Asked Questions
Who can join the NCT06501274 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Eosinophilic Esophagitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06501274 currently recruiting?
Yes, NCT06501274 is actively recruiting participants. Contact the research team at toral.odedra@nhs.net for enrollment information.
Where is the NCT06501274 trial being conducted?
This trial is being conducted at Stevenage, United Kingdom.
Who is sponsoring the NCT06501274 clinical trial?
NCT06501274 is sponsored by East and North Hertfordshire NHS Trust. The principal investigator is Danielle Morris, MD FRCP at East and North Herts NHS Trust. The trial plans to enroll 140 participants.