Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium
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|ClinicalTrials.gov Identifier: NCT01293448|
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : January 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Barrett's Esophagus Esophageal Cancer||Device: Cryoballoon Ablation||Phase 1|
|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.
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|