Clinical Study to Evaluate CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium

April 21, 2022 updated by: Pentax Medical

Clinical Study to Evaluate the CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium

This study will evaluate the C2 CryoBalloon™ Full and Swipe Ablation Systems for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy for reasons unrelated to the objective of the study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary outcomes for the study are the safety and treatment effect of the C2 CryoBalloon™ Ablation System. An esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed.

Study Type

Interventional

Enrollment (Actual)

10

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

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center and Cancer 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Minimum of one 3cm area of non-ulcerated columnar-lined esophagus or squamous-lined tissue suitable for ablation
  • Older than 18 years of age
  • Requires a clinically necessary esophagectomy for esophageal cancer or other indications.

Exclusion Criteria:

  • Patient has esophageal narrowing limiting access to the intended sites of ablation

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CryoBalloon™ Full Ablation System
To evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
Device: CryoBalloon™ Full Ablation System
Tissue Ablation using CryoBalloon™ Full Ablation System
Other Names:
  • CryoBalloon Ablation System (360)
Other: CryoBalloon™ Swipe Ablation System
To evaluate CryoBalloon™ Swipe Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
Device: CryoBalloon™ Swipe Ablation System
Tissue Ablation using CryoBalloon™ Swipe Ablation System
Other Names:
  • CryoBalloon Ablation System (90)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of the CryoBalloon™ Full and Swipe Ablation System
Time Frame: 2 weeks
Number of participants with serious, device-related adverse events after treatment with the CryoBalloon™ Swipe Ablation System
2 weeks
Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems
Time Frame: 2 weeks

Evaluated by depth and uniformity of ablation effect in the esophagus based on histopathologic assessment.

Dose response by effect of ablation to submucosa:

0: Normal

  1. Inflammatory cell infiltration
  2. Separation with inflammation
  3. Edema and Necrosis
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Performance: Average Procedure Time
Time Frame: Minutes from start to end of procedure
Average Procedure time as measured from start to finish of ablation.
Minutes from start to end of procedure
Device Performance: Ease of Deployment of Device
Time Frame: Minutes, from start to end of procedure
Likert Scale measuring physician satisfaction. 0 (worst) to 10 (best)
Minutes, from start to end of procedure

Collaborators and Investigators

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

Sponsor

Pentax Medical

Investigators

  • Principal Investigator: Brian Louie, MD, Swedish Medical Center and Cancer Institute

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

April 1, 2016

Primary Completion (Actual)

October 24, 2016

Study Completion (Actual)

October 30, 2016

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (Estimate)

April 6, 2016

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CP0014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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