- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01293448
Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium
April 21, 2022 updated by: Pentax Medical
The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to evaluate the histological results of a cryoablation technique used to ablate human esophageal mucosa.
The performance and safety of the cryoablation technique will also be evaluated.
Study Type
Interventional
Enrollment (Actual)
21
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
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AZ
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Amsterdam, AZ, Netherlands, 1105
- AMC
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-
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California
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Los Angeles, California, United States, 90033
- University of Southern California
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New York
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Rochester, New York, United States, 14642
- University of Rochester
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- University of Pittsburgh
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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
Description
Inclusion Criteria:
- Patient must have a minimum of 2.0 cm of non-ulcerated, non-inflammatory columnar-lined esophagus or squamous esophageal lined tissue suitable for ablation. A patient may be treated with up to 2 zones of ablation.
- Patient is 18 to 80 years of age at the time of consent (inclusive).
- Patient has provided written Informed Consent Form (IFC) using a form that has been approved by the Institution's reviewing IRB/EC.
- Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
- Patient's esophagectomy is clinically necessary due to reasons unrelated to this study.
- Patient is deemed operable per standard institutional criteria.
Exclusion Criteria:
- Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to IFC, post treatment instructions or follow-up guidelines.
- Patient refuses or is unable to provide written informed consent. - -
- Patient has or is currently undergoing endoscopic ablation therapy within 4 cm from the proposed treatment area including, but not limited to cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
- Patient has esophageal narrowing limiting access to the intended site of ablation.
- Patient is undergoing or has recently undergone chemotherapy (within 15 days or WBC below normal by institutional criteria or standards).
- Patient is undergoing or has recently undergone radiation therapy which involved the esophagus (within 15 days or WBC below normal by institutional criteria or standards).
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: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Intervention
CryoBalloon ablation of esophageal tissue in patients scheduled for esophagectomy for reasons unrelated to the objective of the study.
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Device: CryoBalloon Ablation System(TM) C2 Therapeutics Inc. received FDA market clearance for the CryoBalloon Ablation System on September 29, 2010.
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."
(K101825)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment effect
Time Frame: Within 30 days of ablation procedure
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The primary outcome measure is to evaluate the histological results (depth of injury) of a cryoballoon ablation system.
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Within 30 days of ablation procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-ablation symptoms
Time Frame: Within 7 days of ablation procedure
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A secondary outcome measure is to evaluate post-ablation symptoms - number of participants with adverse events as a measure of safety and tolerability.
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Within 7 days of ablation procedure
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Post procedure pain
Time Frame: Within 7 days of ablation procedure
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The secondary objective of the study is to determine patient comfort post-procedure.
Pain scores are measured on a numerical pain intensity scale.
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Within 7 days of ablation procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jacques Bergman, MD, AIDS Malignancy Consortium
- Principal Investigator: Steve DeMeester, MD, University of Southern California
- Principal Investigator: Blair Jobe, MD, University of Pittsburgh
- Principal Investigator: Jeffery Peters, MD, University of Rochester
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, 2010
Primary Completion (ACTUAL)
January 1, 2012
Study Completion (ACTUAL)
January 1, 2012
Study Registration Dates
First Submitted
December 14, 2010
First Submitted That Met QC Criteria
February 9, 2011
First Posted (ESTIMATE)
February 10, 2011
Study Record Updates
Last Update Posted (ACTUAL)
April 28, 2022
Last Update Submitted That Met QC Criteria
April 21, 2022
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP-0001.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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