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Evaluation of Safety and Dose Response Using C2 CryoBalloon™ Swipe Ablation System for Barrett's Esophagus

NCT03097666 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-04-22

No results posted yet for this study

Summary

The primary objective is to determine the safety and efficacy of the C2 CryoBalloon™ Swipe Ablation System ("CryoBalloon Swipe") used at increasing doses.

Conditions

  • Barrett Esophagus

Interventions

DEVICE

C2 CRYOBALLOON SWIPE ABLATION SYSTEM

The C2 CryoBalloon Swipe Ablation System ("CryoBalloon Swipe") is a cryosurgical device with a nitrous oxide cooled balloon probe that is compatible with upper gastrointestinal diagnostic endoscopes.

Sponsors & Collaborators

  • Pentax Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2018-11-01
Completion
2018-11-01
FDA Device
Yes

Countries

  • 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 NCT03097666 on ClinicalTrials.gov