esophageal cancer esophageal neoplasm
Conditions
Interventions
Treatment with the Coldplay CryoBalloon Ablation Systems (Full and/or Swipe)
Sponsors
C2 Therapeutics
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. 1 or 2 areas of 3 cm non-ulcerated columnar-lined esophagus or squamous- lined tissue suitable for ablation. Each ablation zone should be at least 1 cm from the tumor and a minimum of 3 cm in length. Sequential ablation zones must be a minimum of 1 cm apart. 2. Patient is older than 18 years of age at the time of consent. 3. Patient requires a clinically-necessary esophagectomy for esophageal cancer. 4. Patient has provided written informed consent using the Informed Consent Form (ICF) approved by the Institution*s reviewing Medical Ethics Committee (MEC).
Exclusion criteria
Exclusion criteria: 1. Patient refuses or is unable to provide written informed consent. 2. Patient has esophageal narrowing limiting access to the intended site of ablation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of the CryoBalloon Ablation Systems (Full and Swipe) will be evaluated by the incidence of serious, device-related events. Device performance will be evaluated by ease of deployment (length of time), scope compatibility, application of cryogenic fluid, device malfunction (eg., unresponsive trigger, failure to diffuse nitrous oxide, etc.). | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment effect of the Coldplay CryoBalloon Full and Swipe Ablation Systems will be evaluated by depth and uniformity of ablation effect in the esophagus. An esophagectomy will be performed immediately following the ablation procedure; histopathological analysis of surgically-resected specimens will be done. | — |
Countries
Netherlands
Outcome results
None listed