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

Primary Purpose

Barrett Esophagus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biopsy
Biospecimen Collection
Endoscopic Procedure
Swallowable Sponge Cell Sampling Device
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Barrett Esophagus focused on measuring Barrett's, esophagus, reflux, esophageal adenocarcinoma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mayo Clinic
  • Mayo Clinic
  • Mayo Clinic Health System - Mankato
  • Mayo Clinic in Rochester
  • Northwell Health
  • Baylor University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase 1: Sponge on a String 25 mm 10 pores/inch

Phase 1: Sponge on a String 25 mm 20 pores/inch

Phase 2: Cases - Barrett's Esophagus

Phase 2: Controls - No Barrett's Esophagus

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 21, 2015
Last Updated
November 14, 2022
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI), Exact Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02560623
Brief Title
A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus
Official Title
Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma by a Sponge on String Device
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2015 (Actual)
Primary Completion Date
June 29, 2021 (Actual)
Study Completion Date
July 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI), Exact Sciences Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus
Keywords
Barrett's, esophagus, reflux, esophageal adenocarcinoma

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1: Sponge on a String 25 mm 10 pores/inch
Arm Type
Experimental
Arm Description
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
Arm Title
Phase 1: Sponge on a String 25 mm 20 pores/inch
Arm Type
Experimental
Arm Description
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
Arm Title
Phase 2: Cases - Barrett's Esophagus
Arm Type
Experimental
Arm Description
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
Arm Title
Phase 2: Controls - No Barrett's Esophagus
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Other Intervention Name(s)
BIOPSY_TYPE, Bx
Intervention Description
Undergo biopsy
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection, Biospecimen Collected, Specimen Collection
Intervention Description
Undergo collection of blood sample
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Procedure
Other Intervention Name(s)
Endoscopic Examination, Endoscopy
Intervention Description
Undergo endoscopy
Intervention Type
Device
Intervention Name(s)
Swallowable Sponge Cell Sampling Device
Other Intervention Name(s)
Cytosponge, Swallowable Sponge, Swallowable Sponge Device
Intervention Description
Undergo swallowable sponge cell sampling assessment
Primary Outcome Measure Information:
Title
Number of Subjects That Would Have This Procedure Again
Description
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?"
Time Frame
Within 24 hours of the capsule sponge administration
Title
Tolerability of Swallowing the Sponge Device
Description
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.
Time Frame
Within 24 hours of the capsule sponge administration
Title
Mucosal Irritation
Description
Measured using a mucosal injury score (ranging from 1=no trauma to 5=severe) was scored from video recordings of the subsequent endoscopy conducted
Time Frame
Within 24 hours of the capsule sponge administration
Title
DNA Yield
Description
Total amount of DNA obtained from esophageal cytology specimens collected by the capsule sponge devices.
Time Frame
Within 24 hours of the capsule sponge administration
Secondary Outcome Measure Information:
Title
Sensitivity of Barrett's Dysplasia Detection
Description
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.
Time Frame
Within 24 hours of the capsule sponge administration
Title
Specificity of Barrett's Dysplasia Detection
Description
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.
Time Frame
Within 24 hours of the capsule sponge administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prasad G Iyer, M.D.
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic Health System - Mankato
City
Mankato
State/Province
Minnesota
ZIP/Postal Code
56001
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Northwell Health
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33857451
Citation
Iyer PG, Taylor WR, Slettedahl SW, Lansing RL, Hemminger LL, Cayer FK, Mahoney DW, Giakoumopoulos M, Allawi HT, Wu TT, Wang KK, Wolfsen HC, Antpack E, Kisiel JB. Validation of a methylated DNA marker panel for the nonendoscopic detection of Barrett's esophagus in a multisite case-control study. Gastrointest Endosc. 2021 Sep;94(3):498-505. doi: 10.1016/j.gie.2021.03.937. Epub 2021 Apr 20.
Results Reference
derived
PubMed Identifier
29891853
Citation
Iyer PG, Taylor WR, Johnson ML, Lansing RL, Maixner KA, Yab TC, Simonson JA, Devens ME, Slettedahl SW, Mahoney DW, Berger CK, Foote PH, Smyrk TC, Wang KK, Wolfsen HC, Ahlquist DA. Highly Discriminant Methylated DNA Markers for the Non-endoscopic Detection of Barrett's Esophagus. Am J Gastroenterol. 2018 Aug;113(8):1156-1166. doi: 10.1038/s41395-018-0107-7. Epub 2018 Jun 12.
Results Reference
derived

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

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