NL-OMON39784
Completed
Not Applicable
Evaluation of Balloon-based Focal Cryoablation of Human Esophageal Epithelium - EBCA Focal
C2 Therapeutics0 sites29 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- esophageal cancer
- Sponsor
- C2 Therapeutics
- Enrollment
- 29
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a) Patients with known high grade dysplasia or early adenocarcinoma in BE.
- •b) Patients scheduled for ablation\- and/or EMR\-therapy gastroscopies, during which cryoablation may be performed.
- •c) Patient is 18 to 80 years of age at the time of consent (inclusive).
- •d) Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution\*s reviewing IRB/EC.
- •e) Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
- •f) Patient is deemed operable per standard institutional criteria.
- •g) Each patient has a C\&M classification of C\*2 and/or M\*3\.
- •h) Each patient will have one area of BE or one island of BE \>1 cm2 where the Cryoballoon Focal Ablation System can be successfully positioned within the BE lesion. Cryoballoon ablation should be performed within 1 cm of the proximal border of the Barrett\*s epithelium.
- •i) BE lesion within the treatment zone should be flat.
Exclusion Criteria
- •a) Patient with endoscopically active inflammation in the treatment zone
- •b) Esophageal stenosis preventing advancement of a therapeutic endoscope and/or within 4 cm of treatment zone.
- •c) Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post treatment instructions or follow\-up guidelines.
- •d) Patient refuses or is unable to provide written informed consent.
- •e) Patients that received prior treatment with any energy\-based ablation system.
- •f) Endoscopically visible abnormalities such as masses or nodules within 4 cm of the treatment zone.
Outcomes
Primary Outcomes
Not specified
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