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Cytosponge Adequacy Study Evaluation II

NCT02395471 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2019-07-30

Study results available
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Summary

This study will assess the Minimally Invasive Esophageal Cytology Collection System in Patients with Barrett's Esophagus or GERD Symptoms.

Conditions

  • Barrett's Esophagus
  • GERD

Interventions

DEVICE

Cytosponge™ Cell Collection Device

Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Amanda Cafaro, BSN · Medtronic Clinical Research Director

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-04-24
Completion
2018-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT02395471 on ClinicalTrials.gov