Clinical Trials Logo

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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT03554356 - Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE) N/A
Completed NCT03015389 - Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Tissue Analysis (WATS3D) For the Detection of High Grade Esophageal Dysplasia and Adenocarcinoma
Completed NCT03434834 - OCT Pilot in Esophagus N/A
Terminated NCT04642690 - Nitrates and IL-8 in Barrett's Esophagus
Completed NCT03468634 - Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy N/A
Recruiting NCT02310230 - An Evaluation of the Utility of the ExSpiron Respiratory Variation Monitor During Upper GI Endoscopy N/A
Completed NCT00217087 - Endoscopic Therapy of Early Cancer in Barretts Esophagus Phase 2
Completed NCT02284802 - Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy N/A
Recruiting NCT05530343 - Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance N/A
Active, not recruiting NCT04151524 - Classification of Adenocarcinoma of the Esophagogastric Junction
Completed NCT00955019 - Novel Method of Surveillance in Barrett's Esophagus Phase 2
Terminated NCT00386594 - Pilot Study of Oral 852A for Elimination of High-Grade Dysplasia in Barrett's Esophagus N/A
Completed NCT00576498 - Novel Imaging Techniques in Barrett's Esophagus N/A
Completed NCT02688114 - Healing of the Esophageal Mucosa After RFA of Barrett's Esophagus N/A
Recruiting NCT06071845 - Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples N/A
Recruiting NCT05056051 - Wide-Area Transepithelial Sampling in Endoscopic Eradication Therapy for Barrett's Esophagus N/A
Recruiting NCT04001478 - Non-invasive Testing for Early oEesophageal Cancer and Dysplasia
Completed NCT03859557 - The Evaluation of Patients With Esophageal and Foregut Disorders With WATS (Wide Area Transepithelial Sample With 3-Dimensional Computer-Assisted Analysis) vs. 4-Quadrant Forceps Biopsy
Completed NCT04587310 - Does Laparoscopic Sleeve Gastrectomy Lead to Barrett's Esophagus, 5-year Esophagogastroduodenoscopy Findings: A Retrospective Cohort Study
Recruiting NCT05107219 - GCC Agonist Signal in the Small Intestine Phase 1