Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501274
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-08-29
Brief Title:
Capsule Sponge Study in Eosinophilic Oesophagitis
Sponsor:
East and North Hertfordshire NHS Trust
Organization:
East and North Hertfordshire NHS Trust
Study Overview
Official Title:
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Cosie
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
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
Detailed Description:
Eosinophilic oesophagitis is a condition characterised by symptoms of dysphagia swallowing difficulties andor food impaction in adults with oesophageal biopsies histology showing a peak eosinophil count of 15 eosinophilshigh power field or 15 eosinophils03mm2 or 60 eosinophils mm2 and the absence of other causes of oesophageal
Evidence suggests that if inadequately treated there is increased risk of oesophageal fibrosis and stricture formation that can lead to progressive dysphagia food bolus obstruction food blockages and increased morbidity The degree of eosinophil infiltration in the mucosa is thought to reflect the disease activity better than patient symptoms
Current guidelines from Europe and newly published national guidelines from the British Society of Gastroenterology from the UK recommend reassessment of oesophageal eosinophilia after treatment to ensure remission This has traditionally involved repeating gastroscopies after each treatment diet -after each food group proton pump inhibitor PPI topical steroids which is unpleasant for patients expensive and labour intensive as well as producing a large carbon footprint
Since the start of the COVID-19 pandemic in January 2020 there has been restricted or delayed access to gastroscopy nationally and consequently many patients with EOE have had their repeat gastroscopies cancelled or postponed increasing the risk of complications from undertreated disease
Capsule sponge Cytosponge and Endosign being the current commercially produced example in the UK is an oesophageal cell sampling device that is a pill on a string The patient swallows the pill with water and the sponge expands in the stomach The nurse withdraws the string after 7 minutes and the sponge collects oesophageal cells on withdrawal The sponge is sent for cytological analysis that identifies cells that can be stained for various biomarkers of Barretts oesophagus TFF3 and markers of dysplasia p53 and atypia as well as the opportunity to look at inflammation and in particular in this setting to assess the number of eosinophils and other histological and inflammatory markers supporting a diagnosis of EOE
The use of Capsule sponge in the diagnosis and monitoring of EOE has been described as an alternative to gastroscopy and a quantitative eosinophil count is possible on cytology to allow sequential assessment The eosinophil count on cytology samples from Capsule sponge are similar to biopsies taken from the same patient at the same time when assessed per high power field area of 03mm2 in a single study
Over 10000 Capsule sponge procedures have now been performed in the UK The Capsule sponge service at East and North Herts trust has now performed over 1000 procedures making the trust the largest UK single site experience
The trial population will involve adult patients over 18 years who are known to have a histological diagnosis of EOE and are under follow up at East and North Herts NHS trust
PreclinicalClinical Data The use of Capsule sponge in the monitoring of EOE has been described in a single prospective cross sectional 2-centre study in USA
There have been no studies to date assessing the clinical value of Capsule sponge in monitoring disease activity or response to treatment in adults in a real-world setting
Rationale
Does the use of Capsule sponge instead of endoscopy and biopsies in monitoring known non-stenotic EOE provide sufficient information to affect management decisions in a real-world setting
Current practice to monitor EOE disease activity with endoscopy and biopsies has been severely affected by the COVID19 pandemic resulting in delays to treatment and the risk of progressive stenotic disease and morbidity
Gastroscopy is invasive expensive unpleasant and aerosol generating whilst Capsule sponge is cheaper much less invasive does not require sedation and is preferred by patients and carries a lower carbon footprint
STUDY OBJECTIVES AND DESIGN Objectives Primary objectives Does Capsule sponge instead of endoscopy and biopsies in monitoring known non stenotic EOE provide sufficient information to affect management decisions in a real-world setting Do patients show a preference for Capsule sponge over endoscopy and biopsies
Secondary objectives
Subgroup analysis by current treatment
Do Symptom scores reflect eosinophil count and other markers of inflammation on cytology and histology
Complications
Failure to swallow rate
Inadequate cytology rate
Gastroscopy rate by 1year if not done simultaneously
Potential Cost savings compared with gastroscopy
Endpointsoutcomes
Primary Endpointsoutcomes
Descriptive analysis of management decision made as a result of the Capsule sponge findings Patient preference for Capsule sponge or gastroscopy
Secondary Endpointsoutcomes
Subgroup analysis by current treatment dietPPItopical steroidcombinationno treatment
Correlation between Symptom scores and eosinophil count and other markers of inflammation on cytology and histology
Additional cytological findings of EOE activity and inflammation
Other cytological findings Barretts oesophagusdysplasiaother diagnoses
Number of Complications
Failure to swallow rate
Inadequate cytology rate
Gastroscopy rate if not done simultaneously
Cost savings
Patient satisfaction and pain scores
Study Design
Purpose of research To identify a suitable alternative to endoscopic biopsies for monitoring patients with non-stenotic EOE
Real-world prospective pragmatic interventional study in a single district general hospital secondary care setting with quantitative and qualitative outcome measures Design chosen as pragmatic and comparative control study with endoscopy would be impractical due to COVID backlog cost and such a study has already been performed
Data collection methods
An excel database of patients with EOE will be established and used as a screening log
With demographic data date of diagnosis date of previous endoscopies endoscopic findings EREFS criteria if documented eosinophil count on previous histology and any other histological supportive features current and previous treatments documented Reasons for ineligibility will also be documented
The study will be discussed with eligible patients at their normal clinic appointment and for eligible patients who agree to enrol in the study
The following will be sent to patient by emailpost as preferred and the Capsule sponge service contact email and phone details
Eligible patients will be sent copies of the trust standard Capsule sponge procedure information leaflet
Copies of patient Information leaflet regarding the COSiE trial
Study specific Consent form
2 week symptoms diary Dysphagia Symptom Questionnaire DSQ
The following will be administered with the patient on the day of the Capsule sponge procedure
Capsule sponge eligibility and safety questionnaire
Documentation of Current treatment and duration and compliance
Patient satisfaction survey after procedure
Patient participation opinion group has been completed
Number of subjects A total of 100 -140 evaluable patients will be enrolled in the study This is thought to be an achievable sufficiently large sample target given the prevalence of EOE in the catchment population The PI runs a dedicated EOE teleclinic every month that sees approximately 12 patients It is estimated that 23 of these would be eligible for Capsule sponge In addition other patients with EOE are also followed up in 5 other consultant gastroenterology clinics that would be eligible for the study
Study Duration The length of time the study is expected to run over 2 years in order to recruit sufficiently large sample
Evidence suggests that if inadequately treated there is increased risk of oesophageal fibrosis and stricture formation that can lead to progressive dysphagia food bolus obstruction food blockages and increased morbidity The degree of eosinophil infiltration in the mucosa is thought to reflect the disease activity better than patient symptoms
Current guidelines from Europe and newly published national guidelines from the British Society of Gastroenterology from the UK recommend reassessment of oesophageal eosinophilia after treatment to ensure remission This has traditionally involved repeating gastroscopies after each treatment diet -after each food group proton pump inhibitor PPI topical steroids which is unpleasant for patients expensive and labour intensive as well as producing a large carbon footprint
Since the start of the COVID-19 pandemic in January 2020 there has been restricted or delayed access to gastroscopy nationally and consequently many patients with EOE have had their repeat gastroscopies cancelled or postponed increasing the risk of complications from undertreated disease
Capsule sponge Cytosponge and Endosign being the current commercially produced example in the UK is an oesophageal cell sampling device that is a pill on a string The patient swallows the pill with water and the sponge expands in the stomach The nurse withdraws the string after 7 minutes and the sponge collects oesophageal cells on withdrawal The sponge is sent for cytological analysis that identifies cells that can be stained for various biomarkers of Barretts oesophagus TFF3 and markers of dysplasia p53 and atypia as well as the opportunity to look at inflammation and in particular in this setting to assess the number of eosinophils and other histological and inflammatory markers supporting a diagnosis of EOE
The use of Capsule sponge in the diagnosis and monitoring of EOE has been described as an alternative to gastroscopy and a quantitative eosinophil count is possible on cytology to allow sequential assessment The eosinophil count on cytology samples from Capsule sponge are similar to biopsies taken from the same patient at the same time when assessed per high power field area of 03mm2 in a single study
Over 10000 Capsule sponge procedures have now been performed in the UK The Capsule sponge service at East and North Herts trust has now performed over 1000 procedures making the trust the largest UK single site experience
The trial population will involve adult patients over 18 years who are known to have a histological diagnosis of EOE and are under follow up at East and North Herts NHS trust
PreclinicalClinical Data The use of Capsule sponge in the monitoring of EOE has been described in a single prospective cross sectional 2-centre study in USA
There have been no studies to date assessing the clinical value of Capsule sponge in monitoring disease activity or response to treatment in adults in a real-world setting
Rationale
Does the use of Capsule sponge instead of endoscopy and biopsies in monitoring known non-stenotic EOE provide sufficient information to affect management decisions in a real-world setting
Current practice to monitor EOE disease activity with endoscopy and biopsies has been severely affected by the COVID19 pandemic resulting in delays to treatment and the risk of progressive stenotic disease and morbidity
Gastroscopy is invasive expensive unpleasant and aerosol generating whilst Capsule sponge is cheaper much less invasive does not require sedation and is preferred by patients and carries a lower carbon footprint
STUDY OBJECTIVES AND DESIGN Objectives Primary objectives Does Capsule sponge instead of endoscopy and biopsies in monitoring known non stenotic EOE provide sufficient information to affect management decisions in a real-world setting Do patients show a preference for Capsule sponge over endoscopy and biopsies
Secondary objectives
Subgroup analysis by current treatment
Do Symptom scores reflect eosinophil count and other markers of inflammation on cytology and histology
Complications
Failure to swallow rate
Inadequate cytology rate
Gastroscopy rate by 1year if not done simultaneously
Potential Cost savings compared with gastroscopy
Endpointsoutcomes
Primary Endpointsoutcomes
Descriptive analysis of management decision made as a result of the Capsule sponge findings Patient preference for Capsule sponge or gastroscopy
Secondary Endpointsoutcomes
Subgroup analysis by current treatment dietPPItopical steroidcombinationno treatment
Correlation between Symptom scores and eosinophil count and other markers of inflammation on cytology and histology
Additional cytological findings of EOE activity and inflammation
Other cytological findings Barretts oesophagusdysplasiaother diagnoses
Number of Complications
Failure to swallow rate
Inadequate cytology rate
Gastroscopy rate if not done simultaneously
Cost savings
Patient satisfaction and pain scores
Study Design
Purpose of research To identify a suitable alternative to endoscopic biopsies for monitoring patients with non-stenotic EOE
Real-world prospective pragmatic interventional study in a single district general hospital secondary care setting with quantitative and qualitative outcome measures Design chosen as pragmatic and comparative control study with endoscopy would be impractical due to COVID backlog cost and such a study has already been performed
Data collection methods
An excel database of patients with EOE will be established and used as a screening log
With demographic data date of diagnosis date of previous endoscopies endoscopic findings EREFS criteria if documented eosinophil count on previous histology and any other histological supportive features current and previous treatments documented Reasons for ineligibility will also be documented
The study will be discussed with eligible patients at their normal clinic appointment and for eligible patients who agree to enrol in the study
The following will be sent to patient by emailpost as preferred and the Capsule sponge service contact email and phone details
Eligible patients will be sent copies of the trust standard Capsule sponge procedure information leaflet
Copies of patient Information leaflet regarding the COSiE trial
Study specific Consent form
2 week symptoms diary Dysphagia Symptom Questionnaire DSQ
The following will be administered with the patient on the day of the Capsule sponge procedure
Capsule sponge eligibility and safety questionnaire
Documentation of Current treatment and duration and compliance
Patient satisfaction survey after procedure
Patient participation opinion group has been completed
Number of subjects A total of 100 -140 evaluable patients will be enrolled in the study This is thought to be an achievable sufficiently large sample target given the prevalence of EOE in the catchment population The PI runs a dedicated EOE teleclinic every month that sees approximately 12 patients It is estimated that 23 of these would be eligible for Capsule sponge In addition other patients with EOE are also followed up in 5 other consultant gastroenterology clinics that would be eligible for the study
Study Duration The length of time the study is expected to run over 2 years in order to recruit sufficiently large sample
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None