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

April 21, 2022 updated by: Pentax Medical
This is a feasibility study without a primary study hypothesis or statistical comparison.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to assess the safety, feasibility, and performance of the C2 Focal Cryoablation Device in patients with Barrett's Esophagus (BE). At 6 to 8 weeks, the patient will receive a follow-endoscopy to assess stricture formation along with biopsy samples taken.

Post-operative pain will be noted. Additionally, biopsy samples will be evaluated for the presence of residual Barrett's Esophagus. Through evaluation of the histological results, treatment parameters for the ablation of human esophageal epithelium will be better understood.

Evaluations include, but are not limited to the following:

  • Deployment ease/scope compatibility.
  • Device malfunctions.
  • Time of catheter deployment.
  • Adverse events.
  • Stricture formation at 6 to 8 weeks.
  • Patient Pain.
  • Histological evaluation of treatment zone at 6 to 8 weeks for presence of residual Barrett's Esophagus.

Study Type

Observational

Enrollment (Actual)

39

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

  • Netherlands
      • Amsterdam, Netherlands
        • Academic Medical Center Amsterdam
      • Nieuwegein, Netherlands
        • St. Antonius Hospital
      • Utrecht, Netherlands
        • Universitair Medisch Centrum Utrecht
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • John Hopkins
    • New York
      • New York, New York, United States, 10032
        • Columbia Medical Center
      • Rochester, New York, United States, 14642
        • University of Rochester
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny-Singer Research Institute

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

Sampling Method

Non-Probability Sample

Study Population

Patients with Barrett's esophagus with or without dysplasia

Description

Inclusion Criteria:

  1. Patients scheduled for ablation, EMR, and/or surveillance for BE (with or without dysplasia). Patient is 18 to 80 years of age at the time of consent (inclusive).
  2. Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution's reviewing IRB/EC.
  3. Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
  4. Patient is deemed operable per standard institutional criteria.

Exclusion Criteria:

  1. Patient with endoscopically active inflammation in the treatment zone
  2. Esophageal stenosis preventing advancement of a therapeutic endoscope and/or within 4 cm of treatment zone.
  3. Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post treatment instructions or follow-up guidelines.
  4. Patient refuses or is unable to provide written informed consent.
  5. Patients that are pregnant.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort A
Subjects in Cohort A will receive 6 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.
Device: Focal Cryoballoon Ablation System - 6 seconds
Ablation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. 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."
Cohort B
Subjects in Cohort B will receive 8 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.
Device: Focal Cryoballoon Ablation System - 8 seconds
Ablation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. 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."
Cohort C
Subjects in Cohort C will receive 10 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.
Device: CryoBalloon Focal Ablation System - 10 seconds
Ablation of Barrett's Esophagus using the Focal CryoBalloon Ablation System. 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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Esophageal Stricture
Time Frame: 6 to 8 Weeks
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).
6 to 8 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-procedure pain relative
Time Frame: Pre-ablation,12 hrs post ablation, 2 days (+ or - 1 day)
A secondary objective of the study is to determine patient comfort post-procedure. Pain scores are measured on a numerical pain intensity scale (0 to 10). Patients is asked to score pain level in the treatment area and swallowing.
Pre-ablation,12 hrs post ablation, 2 days (+ or - 1 day)
Presence of Residual Barrett's Esophagus
Time Frame: 6 to 8 weeks

Esophageal tissue subjected to ablation via the CryoBalloon Focal Ablation System will be submitted for histological evaluation. The evaluation will include:

  1. detailed description of the presence of Barrett's Esophagus and/or squamous mucosa.
  2. estimate of percentage of residual Barrett's in each sample
  3. the detailed description of any residual injury at all levels within the sample.
6 to 8 weeks

Collaborators and Investigators

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

Sponsor

Pentax Medical

Investigators

  • Principal Investigator: Bas L Weusten, MD, pHD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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, 2011

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

June 28, 2012

First Submitted That Met QC Criteria

June 29, 2012

First Posted (ESTIMATE)

July 4, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-0003.A

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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