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

Barrett Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02560623
• Other study ID #: 15-004540
• Secondary ID: NCI-2022-0839015
• Status: Completed
• Phase: N/A
• Start date: October 15, 2015
• Est. completion date: July 8, 2021

Study information

• Verified date: November 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: July 8, 2021
• Est. primary completion date: June 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Barrett Esophagus

Intervention

Procedure:
• Biopsy
Undergo biopsy
• Biospecimen Collection
Undergo collection of blood sample
• Endoscopic Procedure
Undergo endoscopy

Device:
• Swallowable Sponge Cell Sampling Device
Undergo swallowable sponge cell sampling assessment

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas
United States	Mayo Clinic	Jacksonville	Florida
United States	Northwell Health	Manhasset	New York
United States	Mayo Clinic Health System - Mankato	Mankato	Minnesota
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	Exact Sciences Corporation, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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