A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus

Study Overview
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Brief Summary
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This study is being done to collect data on the potential use of a sponge on a string device as a non-invasive tool in evaluating patients with Barrett's Esophagus compared to healthy controls.

Detailed Description
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This study will be conducted in two phases: Phase 1 and Phase 2. Phase 1 will consist of determining the most optimal sponge on a string design (25 mm sponge 20 pores/inch or 25 mm sponge 10 pores/inch) chosen based on participant acceptance, tolerability, mucosal irritation and DNA yield, using a randomized factorial design pilot trial. Participants will first undergo the sponge on a string test followed by clinical endoscopy. Following completion of Phase 1 trial, the most optimal sponge on a string configuration will be chosen for Phase 2. Phase 2 will be conducted using a single size sponge with the same porosity configuration selected from Phase 1. Study procedures, testing and follow up will be the same as Phase 1.

Official Title
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Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma by a Sponge on String Device

Conditions
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Barrett Esophagus

Intervention / Treatment
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* Procedure: Biopsy
* Procedure: Biospecimen Collection
* Procedure: Endoscopic Procedure
* Device: Swallowable Sponge Cell Sampling Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with known Barrett's Esophagus (BE). Patients with a BE segment ≥ 1cm in maximal extent endoscopically. Histology showing evidence of intestinal metaplasia with or without presence of dysplasia. Undergoing clinically indicated endoscopy. Subjects without known evidence of BE - Undergoing clinically indicated diagnostic endoscopy Exclusion Criteria: Subjects with known BE. Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection alone will not be excluded. Patients with history of esophageal resection for esophageal carcinoma. Subjects with or without known evidence of BE (on history or review of medical records). Pregnant or lactating females. Patients who are unable to consent. Patients with current history of eosinophilic esophagitis, achalasia or uninvestigated dysphagia. Patients on oral anticoagulation including Coumadin, Warfarin. Patients on antiplatelet agents including Clopidogrel, unless discontinued for 3 days prior to the sponge procedure. Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for 3 days prior to the sponge procedure. Patients with history of known varices or cirrhosis. Patients with history of esophageal resection for esophageal carcinoma. Patients with congenital or acquired bleeding diatheses. Patients with a history of esophageal squamous dysplasia. Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1: Sponge on a String 25 mm 10 pores/inch<br>In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy | Procedure: Biopsy<br>* Undergo biopsy<br>* Other names: Bx;Procedure: Biospecimen Collection<br>* Undergo collection of blood sample<br>* Other names: Specimen Collection;Procedure: Endoscopic Procedure<br>* Undergo endoscopy<br>* Other names: Endoscopy;Device: Swallowable Sponge Cell Sampling Device<br>* Undergo swallowable sponge cell sampling assessment<br>* Other names: Swallowable Sponge Device;|
| Experimental: Phase 1: Sponge on a String 25 mm 20 pores/inch<br>In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy | Procedure: Biopsy<br>* Undergo biopsy<br>* Other names: Bx;Procedure: Biospecimen Collection<br>* Undergo collection of blood sample<br>* Other names: Specimen Collection;Procedure: Endoscopic Procedure<br>* Undergo endoscopy<br>* Other names: Endoscopy;Device: Swallowable Sponge Cell Sampling Device<br>* Undergo swallowable sponge cell sampling assessment<br>* Other names: Swallowable Sponge Device;|
| Experimental: Phase 2: Cases - Barrett's Esophagus<br>In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy | Procedure: Biopsy<br>* Undergo biopsy<br>* Other names: Bx;Procedure: Endoscopic Procedure<br>* Undergo endoscopy<br>* Other names: Endoscopy;Device: Swallowable Sponge Cell Sampling Device<br>* Undergo swallowable sponge cell sampling assessment<br>* Other names: Swallowable Sponge Device;|
| Experimental: Phase 2: Controls - No Barrett's Esophagus<br>In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy | Procedure: Biopsy<br>* Undergo biopsy<br>* Other names: Bx;Procedure: Endoscopic Procedure<br>* Undergo endoscopy<br>* Other names: Endoscopy;Device: Swallowable Sponge Cell Sampling Device<br>* Undergo swallowable sponge cell sampling assessment<br>* Other names: Swallowable Sponge Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects That Would Have This Procedure Again | Number of subjects that answered yes to the self-reported question Would you choose to have this procedure again to screen for Barrett's esophagus? | Within 24 hours of the capsule sponge administration | 
| Tolerability of Swallowing the Sponge Device | Measured using a self-reported 5-item tolerability assessment rating discomfort during the procedure on a Likert scale of 0-10; 10 representing the worst experience and 0 the best experience. This scale allows a comprehensive and individual assessment of the degree of pain, choking, gagging, anxiety and overall experienced during the procedure. | Within 24 hours of the capsule sponge administration | 
| Mucosal Irritation | Measured using a mucosal injury score (ranging from 1=no trauma to 5=severe) was scored from video recordings of the subsequent endoscopy conducted | Within 24 hours of the capsule sponge administration | 
| DNA Yield | Total amount of DNA obtained from esophageal cytology specimens collected by the capsule sponge devices. | Within 24 hours of the capsule sponge administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Barrett's Dysplasia Detection | The sensitivity methylated DNA markers detected by the capsule sponge, in making a diagnosis of BE related dysplasia will be assessed using endoscopic surveillance biopsy histology as a gold standard. | Within 24 hours of the capsule sponge administration | 
| Specificity of Barrett's Dysplasia Detection | The specificity of methylated DNA markers detected by the capsule sponge, in identifying subjects without a diagnosis of BE related dysplasia will be assessed using endoscopic surveillance biopsy histology as a gold standard. | Within 24 hours of the capsule sponge administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barrett's, esophagus, reflux, esophageal adenocarcinoma