Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium
The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.
Device: Cryoballoon Ablation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium|
- Treatment effect [ Time Frame: Within 30 days of ablation procedure ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]The secondary objective of the study is to determine patient comfort post-procedure. Pain scores are measured on a numerical pain intensity scale.
|Study Start Date:||December 2010|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
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)
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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 Clinical Trials 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|