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

NCT02560623 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2022-11-17

Study results available
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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.

Conditions

  • Barrett Esophagus

Interventions

PROCEDURE

Biopsy

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood sample

PROCEDURE

Endoscopic Procedure

Undergo endoscopy

DEVICE

Swallowable Sponge Cell Sampling Device

Undergo swallowable sponge cell sampling assessment

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Exact Sciences Corporation

    collaborator INDUSTRY
  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Prasad G Iyer, M.D. · Mayo Clinic in Rochester

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-15
Primary Completion
2021-06-29
Completion
2021-07-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02560623 on ClinicalTrials.gov