Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

April 21, 2022 updated by: Pentax Medical
The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the histological results of a cryoablation technique used to ablate human esophageal mucosa. The performance and safety of the cryoablation technique will also be evaluated.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • AZ
      • Amsterdam, AZ, Netherlands, 1105
        • AMC
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient must have a minimum of 2.0 cm of non-ulcerated, non-inflammatory columnar-lined esophagus or squamous esophageal lined tissue suitable for ablation. A patient may be treated with up to 2 zones of ablation.
  • Patient is 18 to 80 years of age at the time of consent (inclusive).
  • Patient has provided written Informed Consent Form (IFC) using a form that has been approved by the Institution's reviewing IRB/EC.
  • Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
  • Patient's esophagectomy is clinically necessary due to reasons unrelated to this study.
  • Patient is deemed operable per standard institutional criteria.

Exclusion Criteria:

  • Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to IFC, post treatment instructions or follow-up guidelines.
  • Patient refuses or is unable to provide written informed consent. - -
  • Patient has or is currently undergoing endoscopic ablation therapy within 4 cm from the proposed treatment area including, but not limited to cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
  • Patient has esophageal narrowing limiting access to the intended site of ablation.
  • Patient is undergoing or has recently undergone chemotherapy (within 15 days or WBC below normal by institutional criteria or standards).
  • Patient is undergoing or has recently undergone radiation therapy which involved the esophagus (within 15 days or WBC below normal by institutional criteria or standards).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
CryoBalloon ablation of esophageal tissue in patients scheduled for esophagectomy for reasons unrelated to the objective of the study.
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)
Other Names:
  • cryoablation
  • CryoBalloon Ablation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment effect
Time Frame: Within 30 days of ablation procedure
The primary outcome measure is to evaluate the histological results (depth of injury) of a cryoballoon ablation system.
Within 30 days of ablation procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-ablation symptoms
Time Frame: Within 7 days of ablation procedure
A secondary outcome measure is to evaluate post-ablation symptoms - number of participants with adverse events as a measure of safety and tolerability.
Within 7 days of ablation procedure
Post procedure pain
Time Frame: Within 7 days of ablation procedure
The secondary objective of the study is to determine patient comfort post-procedure. Pain scores are measured on a numerical pain intensity scale.
Within 7 days of ablation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Jacques Bergman, MD, AIDS Malignancy Consortium
  • Principal Investigator: Steve DeMeester, MD, University of Southern California
  • Principal Investigator: Blair Jobe, MD, University of Pittsburgh
  • Principal Investigator: Jeffery Peters, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

February 9, 2011

First Posted (ESTIMATE)

February 10, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

January 1, 2018

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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