Esophageal Cancer
Conditions
Brief summary
To evaluate the safety and treatment effect of the CryoBalloon™ Full Ablation System for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy
Detailed description
The primary outcomes for the study are the safety and treatment effect of the CryoBalloon™ Ablation System. An esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed to determine the treatment effect.
Interventions
Tissue Ablation using CryoBalloon Ablation System
Sponsors
Pentax Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Up to two (2) areas of 3 cm each non-ulcerated, columnar lined esophagus or squamous linted tissue suitable for ablation * Older than 18 years of age at the time of consent * Requires a clinically-necessary esophagectomy for esophageal cancer * Patient has provided written informed consent using the Informed Consent Form approved by the Institution's reviewing Medical Ethics Committee (MEC)
Exclusion criteria
* Patient refuses or is unable to provide written informed consent * Patient has esophageal narrowing limiting access to the intended site of ablation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of CryoBalloon Ablation System | through study completion, an average of 2 weeks | Incidence of device related serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Performance | through study completion, an average of 2 weeks | Ease of deployment of the CryoBalloon, procedure time, endoscope compatibility, device malfunction. |
Countries
Netherlands
Outcome results
None listed