NL-OMON36325
Completed
Not Applicable
Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium - EBCA
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- esophageal cancer
- Sponsor
- C2 Therapeutics, Inc.
- Enrollment
- 15
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a) 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
- •b) Patient is 18 to 80 years of age at the time of consent (inclusive).
- •c) Patient has provided written Informed Consent Form (IFC) using a form that has been approved by the Institution\*s reviewing IRB/EC.
- •d) Patient is willing and able to comply with study requirements.
- •e) Patient\*s esophagectomy is clinically necessary due to reasons unrelated to this study.
- •f) Patient is deemed operable per standard institutional criteria.
Exclusion Criteria
- •a) 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.
- •b) Patient refuses or is unable to provide written informed consent.
- •c) 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.
- •d) Patient has esophageal narrowing limiting access to the intended site of ablation.
- •e) Patient is undergoing or has recently undergone chemotherapy (within 15 days or WBC below normal by institutional criteria or standards).
- •f) 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).
Outcomes
Primary Outcomes
Not specified
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