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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02729753
Recruitment Status : Completed
First Posted : April 6, 2016
Results First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Pentax Medical

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Esophageal Cancer Device: CryoBalloon™ Full Ablation System Device: CryoBalloon™ Swipe Ablation System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Clinical Study to Evaluate the CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium
Study Start Date : April 2016
Actual Primary Completion Date : October 24, 2016
Actual Study Completion Date : October 30, 2016

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Arms and Interventions
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Arm Intervention/treatment
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 Name: CryoBalloon Ablation System (360)
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 Name: CryoBalloon Ablation System (90)


Outcome Measures
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Primary Outcome Measures :
  1. 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. 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


Secondary Outcome Measures :
  1. 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.

  2. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729753


Locations
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United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Swedish Medical Center and Cancer Institute
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Pentax Medical
Investigators
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Principal Investigator: Brian Louie, MD Swedish Medical Center and Cancer Institute
More Information
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Responsible Party: Pentax Medical
ClinicalTrials.gov Identifier: NCT02729753    
Other Study ID Numbers: CP0014
First Posted: April 6, 2016    Key Record Dates
Results First Posted: October 12, 2018
Last Update Posted: October 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No