The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
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)
University of Southern California
Los Angeles, California, United States
University of Rochester
Rochester, New York, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
AMC
Amsterdam, AZ, Netherlands
Treatment effect
The primary outcome measure is to evaluate the histological results (depth of injury) of a cryoballoon ablation system.
Time frame: Within 30 days of ablation procedure
Post-ablation symptoms
A secondary outcome measure is to evaluate post-ablation symptoms - number of participants with adverse events as a measure of safety and tolerability.
Time frame: Within 7 days of ablation procedure
Post procedure pain
The secondary objective of the study is to determine patient comfort post-procedure. Pain scores are measured on a numerical pain intensity scale.
Time frame: Within 7 days of ablation procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.