No registrations found.
ID
Source
Brief title
Health condition
Barrett's esophagus
cryoablation
Sponsors and support
Intervention
Outcome measures
Primary outcome
safety and treatment effect of the CryoBalloonTM Ablation Systems. Safety will be evaluated by the incidence of serious, CryoBalloonTM Ablation System-related adverse events. Treatment effect of the CryoBalloonTM 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 performed.
Secondary outcome
The secondary outcome is device performance: ease of deployment, procedure time, endoscope compatibility, and device malfunction.
Background summary
The objective of this study is to evaluate the safety and treatment effect of the CryoBalloonTM Full and Swipe Ablation Systems for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy.
Study objective
The objective of this study is to evaluate the safety and treatment effect of the CryoBalloonTM Full and Swipe Ablation Systems for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy.
Study design
Before esophagectomy, cryoablation will take place and after esophagectomy, the esophagectomy specimen will be analyzed.
Intervention
cryoablation using the Cryoballoon Full and Dwipe Ablation Systems
Academic Medical Center Amsterdam
Meibergdreef 9, C2-231
H.T. Künzli
Amsterdam 1105 AZ
The Netherlands
h.t.kunzli@amc.uva.nl
Academic Medical Center Amsterdam
Meibergdreef 9, C2-231
H.T. Künzli
Amsterdam 1105 AZ
The Netherlands
h.t.kunzli@amc.uva.nl
Inclusion criteria
Patients must meet ALL of the following criteria to be eligible for participation in the study:
1. A minimum of two (2) areas of non-ulcerated columnar-lined esophagus or squamous-lined tissue suitable for ablation. Each ablation zone should be at least 1cm from the tumor and a minimum of 3cm in length. Sequential ablation zones must be a minimum of 1cm apart.
2. Older than 18 years of age at the time of consent.
3. 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
Patients must be excluded if ANY of the following criteria are met:
1. Patient refuses or is unable to provide written informed consent.
2. Patient has esophageal narrowing limiting access to the intended sites of ablation.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5287 |
| NTR-old | NTR5394 |
| CCMO | NL53312.018.15 |
| OMON | NL-OMON43660 |