Evaluation of Balloon-based Focal Cryoablation of Human Esophageal Epithelium - EBCA Focal

C2 Therapeutics0 个研究点目标入组 29 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•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.

•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.

发起方

C2 Therapeutics