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
C2 Therapeutics, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Histological aspect of tissue after balloon based cryoabalation: (1) the percentage of mucosa ablated (**Ablation** is defined as any sign of irreversible injury (necrosis)). (2) the anatomic depth of injury. (3) a detailed description of the type of injury at each depth of the esophageal wall. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Deployment ease/endoscope compatibility. (2) Flow of the cryogenic fluid. (3) Balloon pressure. | — |
Countries
Netherlands
Outcome results
None listed