Barrett's Esophagus, Esophageal Cancer
Conditions
Keywords
Esophagectomy, Barrett's Esophagus
Brief summary
The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.
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.
Interventions
DEVICECryoballoon 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)
Sponsors
Pentax Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment effect | Within 30 days of ablation procedure | The primary outcome measure is to evaluate the histological results (depth of injury) of a cryoballoon ablation system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-ablation symptoms | 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 | 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. |
Countries
Netherlands, United States
Outcome results
None listed