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Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus

NCT01572987 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-05-30

No results posted yet for this study

Summary

This clinical trial will evaluate a patient population with Barrett's esophagus(BE) containing high grade dysplasia or intramucosal cancer and compare the effects of endoscopically-guided radiofrequency ablation system(RFA) and endoscopically-guided stepwise endoscopic mucosal resection(S-EMR).

Conditions

  • Barrett's Esophagus
  • Esophageal Neoplasms

Interventions

DEVICE

Radiofrequency Ablation(RFA) by HALO device.

RFA or Surveillance every 2 months for 1 year.

DEVICE

Endoscopic mucosal resection(EMR) by mucosectomy kit.

EMR or surveillance every 2 months.

Sponsors & Collaborators

  • American Society for Gastrointestinal Endoscopy

    collaborator OTHER

  • Cook Group Incorporated

    collaborator INDUSTRY

  • Washington University School of Medicine

    collaborator OTHER

  • Columbia University

    collaborator OTHER

  • University of Chicago

    collaborator OTHER

  • Midwest Biomedical Research Foundation

    lead OTHER

Principal Investigators

  • Prateek Sharma, MD · Kansas City VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2017-05-31
Completion
2017-05-31

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 NCT01572987 on ClinicalTrials.gov