esophageal cancer esophageal neoplasm
Conditions
Interventions
Endoscopic balloon based cryoablation. The System has two main components: the
delivery catheter with balloon probe and a disposable handle containing the
cryogenic fluid. Deployed through the worki
Sponsors
C2Therapeutics
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: a) Patients with known Barrett*s esophagus, scheduled for treatment with focal radiofrequency ablation (HALO-90) [i.e. in patients with islands or residual Barrett*s after circumferential radiofrequency ablation (HALO-360) or in patients for whom circumferential radiofrequency ablation is not feasible], during which the cryoablation may be performed. b) Patient is 18 to 80 years of age at the time of consent (inclusive). c) Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution*s reviewing IRB/EC. d) Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements. e) Patient is deemed operable per standard institutional criteria. f) Each patient will have one (group of) island of BE *1 cm2 where the Cryoballoon Focal Ablation System can be successfully positioned within the BE lesion. g) BE lesion within the treatment zone should be flat.
Exclusion criteria
Exclusion criteria: a) Esophageal stenosis preventing advancement of a therapeutic endoscope and/or within 4 cm of treatment zone. b) 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. c) Patient refuses or is unable to provide written informed consent. d) Patients that are pregnant. e) Patient with endoscopically active inflammation in the treatment zone. f) Endoscopically visible abnormalities such as masses or nodules requiring endoscopic resection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Efficacy of the CbFAS, defined as the percentage of the (group of) islands with full conversion from Barrett's epithelium to squamous cell epithelium. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Percentage of the (group of) islands with 50% conversion from Barrett's epithelium to squamous cell epithelium. 2) Device performance of theimproved Cryoballoon Focal Ablation System 3) Occurrence of any adverse events. | — |
Countries
Netherlands
Outcome results
None listed