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Clinical Study to Evaluate CryoBalloon™ Ablation System in Patients Undergoing Esophagectomy

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: NCT02729727
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Pentax Medical

Study Description
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Brief Summary:
To evaluate the safety and treatment effect of the CryoBalloon™ Full Ablation System for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy

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

Detailed Description:
The primary outcomes for the study are the safety and treatment effect of the CryoBalloon™ Ablation System. An esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed to determine the treatment effect.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Clinical Study to Evaluate the CryoBalloon™ Full Ablation System for the Ablation of Human Esophageal Epithelium in Patients Undergoing Esophagectomy
Study Start Date : March 2016
Actual Primary Completion Date : June 24, 2016
Actual Study Completion Date : June 30, 2016

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Arms and Interventions
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Arm Intervention/treatment
Single Arm
To evaluate safety and treatment effect of the CryoBalloon Ablation System for the Ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy
 Device: CryoBalloon Ablation System
Tissue Ablation using CryoBalloon Ablation System


Outcome Measures
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Primary Outcome Measures :
  1. Safety of CryoBalloon Ablation System [ Time Frame: through study completion, an average of 2 weeks ]
    Incidence of device related serious adverse events


Secondary Outcome Measures :
  1. Device Performance [ Time Frame: through study completion, an average of 2 weeks ]
    Ease of deployment of the CryoBalloon, procedure time, endoscope compatibility, device malfunction.


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:

  • Up to two (2) areas of 3 cm each non-ulcerated, columnar lined esophagus or squamous linted tissue suitable for ablation
  • Older than 18 years of age at the time of consent
  • Requires a clinically-necessary esophagectomy for esophageal cancer
  • Patient has provided written informed consent using the Informed Consent Form approved by the Institution's reviewing Medical Ethics Committee (MEC)

Exclusion Criteria:

  • Patient refuses or is unable to provide written informed consent
  • Patient has esophageal narrowing limiting access to the intended site of ablation
Contacts and Locations
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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): NCT02729727


Locations
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Netherlands
Academic Medical Centre Amsterdam
Amsterdam, North Holland, Netherlands, 1105
Sponsors and Collaborators
Pentax Medical
Investigators
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Principal Investigator: Jacques J.G.H.M. Bergman, MD, PhD AMC Medical Research B.V.
More Information
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Responsible Party: Pentax Medical
ClinicalTrials.gov Identifier: NCT02729727    
Other Study ID Numbers: CP-0008
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided