Evaluation of Balloon-based Cryoablation 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: NCT01293448|
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : April 28, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Barrett's Esophagus Esophageal Cancer||Device: Cryoballoon Ablation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
CryoBalloon ablation of esophageal tissue in patients scheduled for esophagectomy for reasons unrelated to the objective of the study.
Device: Cryoballoon Ablation
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)
- Treatment effect [ Time Frame: Within 30 days of ablation procedure ]The primary outcome measure is to evaluate the histological results (depth of injury) of a cryoballoon ablation system.
- Post-ablation symptoms [ Time Frame: Within 7 days of ablation procedure ]A secondary outcome measure is to evaluate post-ablation symptoms - number of participants with adverse events as a measure of safety and tolerability.
- Post procedure pain [ Time Frame: Within 7 days of ablation procedure ]The secondary objective of the study is to determine patient comfort post-procedure. Pain scores are measured on a numerical pain intensity scale.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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).
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): NCT01293448
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15232|
|Amsterdam, AZ, Netherlands, 1105|
|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|
|Responsible Party:||Pentax Medical|
|Other Study ID Numbers:||
|First Posted:||February 10, 2011 Key Record Dates|
|Last Update Posted:||April 28, 2022|
|Last Verified:||January 2018|
Digestive System Diseases