Capsule Sponge Study in Eosinophilic Oesophagitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEast and North Hertfordshire NHS Trust

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • capsule sponge

    Device

    capsule sponge sampling device of the oesophagus

Treatment groups

140 Participants
are divided into 1 treatment group
Group A: all eligible patients with non stenotic eosinophilic oesophagitisOther 1 intervention

Trial outcomes

Primary outcomes

1

• 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

Time frame
through study completion, an average of 1 year
2

• symptom score

Dysphagia symptom score (DSQ) scored as continuous variable in 2 weeks prior to capsule sponge

Time frame
through study completion, an average of 1 year
3

• Eosinophil count on cytology

no of eosinophils per high powered field on cytology

Time frame
through study completion, an average of 1 year
4

• Patient pain evaluation

wong -baker faces visual scale from 0 to 10 with 0 being no pain and 10 being maximum pain

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

• Failure to swallow rate

proportion of patients unable to swallow device after 2 attempts

Time frame
through study completion, an average of 1 year
2

• Inadequate sample rate

proportion of samples with inadequate squamous cells for analysis

Time frame
through study completion, an average of 1 year
3

• Complications

recognised immediate complications

Time frame
through study completion, an average of 1 year
4

• Repeat gastroscopy rate

numbers of patients requiring gastroscopy within 1year of sponge

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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