A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus
- Conditions
- Barrett Esophagus
- Interventions
- Procedure: BiopsyProcedure: Biospecimen CollectionProcedure: Endoscopic ProcedureDevice: Swallowable Sponge Cell Sampling Device
- Registration Number
- NCT02560623
- Lead Sponsor
- Mayo Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 242
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
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase 1: Sponge on a String 25 mm 10 pores/inch Endoscopic Procedure 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 Phase 1: Sponge on a String 25 mm 20 pores/inch Swallowable Sponge Cell Sampling Device 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 Phase 1: Sponge on a String 25 mm 20 pores/inch Biopsy 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 Phase 1: Sponge on a String 25 mm 20 pores/inch Biospecimen Collection 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 Phase 1: Sponge on a String 25 mm 20 pores/inch Endoscopic Procedure 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 Phase 2: Controls - No Barrett's Esophagus Endoscopic Procedure 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 Phase 1: Sponge on a String 25 mm 10 pores/inch Biopsy 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 Phase 1: Sponge on a String 25 mm 10 pores/inch Biospecimen Collection 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 Phase 2: Controls - No Barrett's Esophagus Swallowable Sponge Cell Sampling Device 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 Phase 2: Cases - Barrett's Esophagus Endoscopic Procedure 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 Phase 2: Cases - Barrett's Esophagus Swallowable Sponge Cell Sampling Device 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 Phase 2: Cases - Barrett's Esophagus Biopsy 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 Phase 1: Sponge on a String 25 mm 10 pores/inch Swallowable Sponge Cell Sampling Device 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 Phase 2: Controls - No Barrett's Esophagus Biopsy 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (5)
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Northwell Health
🇺🇸Manhasset, New York, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
Mayo Clinic Health System - Mankato
🇺🇸Mankato, Minnesota, United States