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Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

NCT01293448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-04-28

No results posted yet for this study

Summary

The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.

Conditions

  • Barrett's Esophagus
  • Esophageal Cancer

Interventions

DEVICE

Cryoballoon Ablation

Device: CryoBalloon Ablation System(TM) C2 Therapeutics Inc. received FDA market clearance for the CryoBalloon Ablation System on September 29, 2010. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications." (K101825)

Sponsors & Collaborators

  • Pentax Medical

    lead INDUSTRY

Principal Investigators

  • Jacques Bergman, MD · AIDS Malignancy Consortium

  • Steve DeMeester, MD · University of Southern California

  • Blair Jobe, MD · University of Pittsburgh

  • Jeffery Peters, MD · University of Rochester

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States
  • Netherlands

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 NCT01293448 on ClinicalTrials.gov