Clinical Study to Evaluate CryoBalloon™ Ablation System in Patients Undergoing Esophagectomy
NCT ID: NCT02729727
Last Updated: 2022-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3 participants
INTERVENTIONAL
2016-03-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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
CryoBalloon Ablation System
Tissue Ablation using CryoBalloon Ablation System
Interventions
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CryoBalloon Ablation System
Tissue Ablation using CryoBalloon Ablation System
Eligibility Criteria
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Inclusion Criteria
* 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 has esophageal narrowing limiting access to the intended site of ablation
18 Years
ALL
No
Sponsors
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Pentax Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Jacques J.G.H.M. Bergman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
AMC Medical Research B.V.
Locations
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Academic Medical Centre Amsterdam
Amsterdam, North Holland, Netherlands
Countries
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Other Identifiers
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CP-0008
Identifier Type: -
Identifier Source: org_study_id
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