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NCT01633411 · ClinicalTrials.gov registry record

Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

A clinical trial, sponsored by Pentax Medical.

Completed
Registry status
39
Enrollment target

NCT01633411: Completed study, sponsored by Pentax Medical.

NCT01633411 is a clinical trial that has completed, run by Pentax Medical. The registered enrollment target is 39 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01633411 has completed, sponsored by Pentax Medical.

COMPLETED
Registry status
39 participants
Enrollment target

Study Summary

This is a feasibility study without a primary study hypothesis or statistical comparison.

Primary Outcome

Stricture formation is defined as none, mild (non-circumferential stenosis allowing easy passage of diagnostic endoscope), moderate (circular stenosis allowing passage of diagnostic endoscope), and severe (any stenosis preventing the passage of a diagnostic scope).

Interventions

  • DEVICE Focal Cryoballoon Ablation System - 6 seconds
  • DEVICE Focal Cryoballoon Ablation System - 8 seconds
  • DEVICE CryoBalloon Focal Ablation System - 10 seconds

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2011-12
Est. Completion 2014-06
Pentax Medical

4 total trials

What the finished NCT01633411 record still lists

NCT01633411 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 39 participants, a relatively small participant target.

The record links to 0 conditions, and to 3 interventions - of which Focal Cryoballoon Ablation System - 6 seconds is the first listed.

NCT01633411 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01633411 about?

NCT01633411 is a clinical study titled "Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium". This is a feasibility study without a primary study hypothesis or statistical comparison.

What is the current status of trial NCT01633411?

This trial is currently completed. The enrollment target is 39 participants. The study started on 2011-12. Estimated completion is 2014-06.

What interventions are being tested in trial NCT01633411?

The interventions under investigation include: Focal Cryoballoon Ablation System - 6 seconds (DEVICE), Focal Cryoballoon Ablation System - 8 seconds (DEVICE), CryoBalloon Focal Ablation System - 10 seconds (DEVICE).

Who is sponsoring clinical trial NCT01633411?

This trial is sponsored by Pentax Medical, which has 4 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01633411, the US trial registry maintained by the National Library of Medicine. NCT01633411 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.