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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02560623

Enrollment

242

Registered

2015-09-25

Start date

2015-10-15

Completion date

2021-07-08

Last updated

2022-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett Esophagus

Keywords

Barrett's, esophagus, reflux, esophageal adenocarcinoma

Brief summary

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

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.

Interventions

PROCEDUREBiopsy

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood sample

PROCEDUREEndoscopic Procedure

Undergo endoscopy

DEVICESwallowable Sponge Cell Sampling Device

Undergo swallowable sponge cell sampling assessment

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects That Would Have This Procedure Again	Within 24 hours of the capsule sponge administration	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?
Tolerability of Swallowing the Sponge Device	Within 24 hours of the capsule sponge administration	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.
Mucosal Irritation	Within 24 hours of the capsule sponge administration	Measured using a mucosal injury score (ranging from 1=no trauma to 5=severe) was scored from video recordings of the subsequent endoscopy conducted
DNA Yield	Within 24 hours of the capsule sponge administration	Total amount of DNA obtained from esophageal cytology specimens collected by the capsule sponge devices.

Secondary

Measure	Time frame	Description
Sensitivity of Barrett's Dysplasia Detection	Within 24 hours of the capsule sponge administration	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.
Specificity of Barrett's Dysplasia Detection	Within 24 hours of the capsule sponge administration	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Phase 1: Sponge on a String 25 mm 10 Pores/Inch 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 Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.	19
Phase 1:Sponge on a String 25 mm 20 Pores/Inch 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 Capsule Sponge Device 25 mm 20 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.	22
Phase 2: Cases - Barrett's Esophagus 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 Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.	112
Phase 2: Controls - No Barrett's Esophagus 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 Capsule Sponge Device 25 mm 10 pores/inch: Polyurethane foam sponge compressed in a vegetable material derived capsule, attached to a string. The capsule is swallowed by the patient. The shell of the capsule dissolves in the gastric fluid releasing the foam device as a sphere which is then pulled out with the attached string, providing brushing/cytology samples of the proximal stomach and esophagus.	89
Total	242

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Intervention prior to sponge administration	0	1	0	0
Overall Study	Unable to swallow sponge	0	1	0	0

Baseline characteristics

Characteristic	Phase 1:Sponge on a String 25 mm 20 Pores/Inch	Phase 2: Cases - Barrett's Esophagus	Phase 2: Controls - No Barrett's Esophagus	Total	Phase 1: Sponge on a String 25 mm 10 Pores/Inch
Age, Continuous	63.5 years	65.7 years	58.9 years	63 years	64 years
Race and Ethnicity Not Collected	—	—	—	0 Participants	—
Region of Enrollment United States	22 participants	112 participants	89 participants	242 participants	19 participants
Sex: Female, Male Female	11 Participants	20 Participants	47 Participants	83 Participants	5 Participants
Sex: Female, Male Male	11 Participants	92 Participants	42 Participants	159 Participants	14 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 19	0 / 22	0 / 112	0 / 89
other Total, other adverse events	5 / 19	8 / 22	31 / 112	30 / 89
serious Total, serious adverse events	0 / 19	0 / 22	5 / 112	1 / 89

Outcome results

Primary

DNA Yield

Total amount of DNA obtained from esophageal cytology specimens collected by the capsule sponge devices.