Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06501274

Assessment of Capsule Sponge for Monitoring Treatment Response in Non-stenotic Eosinophilic Oesophagitis at a Single Hospital

Led by East and North Hertfordshire NHS Trust · Updated on 2024-07-15

140

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of a Capsule sponge device as an alternative to traditional gastroscopy for monitoring treatment response in adults with non-stenotic eosinophilic oesophagitis (EOE). This condition causes swallowing difficulties and inflammation in the esophagus, and current monitoring requires repeated invasive gastroscopies. The study aims to see if the Capsule sponge provides enough information to guide treatment decisions while assessing patient preference and symptom correlation with eosinophil counts. The Capsule sponge is a pill on a string that collects esophageal cells after being swallowed, allowing for cytological analysis of eosinophil levels and inflammation markers. Patients who have had a change in treatment will be offered this device instead of gastroscopy. Participants will complete a symptom questionnaire for two weeks before the procedure, undergo the Capsule sponge sampling, and then have a follow-up clinic visit about 6-8 weeks later. The study also tracks patient satisfaction, procedure success rates, complications, and possible cost savings. During the study, patients will complete self-administered symptom questionnaires and surveys on satisfaction and pain related to the procedure. The collected samples are analyzed for eosinophil counts and other relevant markers. Researchers will record changes in clinical management based on Capsule sponge findings and follow patients for about one year to observe outcomes like gastroscopy rates and treatment adjustments. The study will enroll 100-140 adults over two years, gathering real-world data on this less invasive monitoring method.

CONDITIONS

Brief Title

Capsule Sponge Study in Eosinophilic Oesophagitis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults diagnosed with non-stenotic eosinophilic oesophagitis who have had a change in treatment
Not Eligible

You will not qualify if you...

  • Presence of strictures or rings preventing gastroscope passage at most recent endoscopy
  • Previous oesophageal dilatation
  • History of oesophageal perforation or surgical resection
  • Diagnosis of oesophago-gastric malignancy
  • Presence of oesophageal varices
  • Recent bolus obstruction requiring hospital visit since last endoscopy
  • Previous fundoplication or complicated hiatus hernia
  • Currently on Warfarin with INR greater than or equal to 3
  • Suspected new diagnosis of eosinophilic oesophagitis without prior endoscopic confirmation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 1 year

Participants undergo the capsule sponge procedure, a less invasive method to sample oesophageal cells for monitoring eosinophilic oesophagitis.

Approximately 1 visit per participant for the capsule sponge procedure

Long-term Monitoring

Duration - Up to 1 year

Participants are monitored for treatment response, symptom scores, complications, and patient preference over the course of the study.

Follow-up assessments as part of routine clinical care; visit frequency varies

Trial Site Locations

Total: 1 location

1

East and North Herts NHS Trust

Stevenage, Hertfordshire, United Kingdom, SG1 4AB

Actively Recruiting

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Research Team

T

Toral Odedra

T

Toral Odedra

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

British Society of Gastroenterology (BSG) and British Society of Paediatric Gastroenterology, Hepatology and Nutrition (BSPGHAN) joint consensus guidelines on the diagnosis and management of eosinophilic oesophagitis in children and adults.

Anjan Dhar, Hasan N Haboubi, Stephen E Attwood...

https://pubmed.ncbi.nlm.nih.gov/35606089

Range of pathologies diagnosed using a minimally invasive capsule sponge to evaluate patients with reflux symptoms.

Anna L Paterson, Pierre Lao-Sirieix, Maria O'Donovan...

https://pubmed.ncbi.nlm.nih.gov/27417524

Accuracy and Safety of the Cytosponge for Assessing Histologic Activity in Eosinophilic Esophagitis: A Two-Center Study.

David A Katzka, Thomas C Smyrk, Jeffrey A Alexander...

https://pubmed.ncbi.nlm.nih.gov/28809387

Safety and Acceptability of Esophageal Cytosponge Cell Collection Device in a Pooled Analysis of Data From Individual Patients.

Wladyslaw Januszewicz, Wei Keith Tan, Katie Lehovsky...

https://pubmed.ncbi.nlm.nih.gov/30099104

Economic evaluation of Cytosponge®-trefoil factor 3 for Barrett esophagus: A cost-utility analysis of randomised controlled trial data.

Nicholas Swart, Roberta Maroni, Beth Muldrew...

https://pubmed.ncbi.nlm.nih.gov/34195582

Psychometric validation of the Dysphagia Symptom Questionnaire in patients with eosinophilic esophagitis treated with budesonide oral suspension.

Stacie Hudgens, Christopher Evans, Elaine Phillips...

https://pubmed.ncbi.nlm.nih.gov/29757322

Development and field testing of a novel patient-reported outcome measure of dysphagia in patients with eosinophilic esophagitis.

E S Dellon, A-M Irani, M R Hill...

https://pubmed.ncbi.nlm.nih.gov/23837796