|- candidate number||22816|
|- NTR Number||NTR5394|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-aug-2015|
|- Secondary IDs||NL53312.018.15 METC 2015_130|
|- Public Title||Clinical study to Evaluate the
Coldplay CryoBalloonTM Full and Swipe Ablation Systems for the Ablation of Human Esophageal Epithelium in Patients Undergoing Esophagectomy
|- Scientific Title||Clinical study to Evaluate the
Coldplay CryoBalloonTM Full and Swipe Ablation Systems for the Ablation of Human Esophageal Epithelium in Patients Undergoing Esophagectomy|
|- hypothesis||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. |
|- Healt Condition(s) or Problem(s) studied||Barrett's esophagus, Cryoablation|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-okt-2015|
|- planned closingdate||1-mrt-2016|
|- Target number of participants||5|
|- Interventions||cryoablation using the Cryoballoon Full and Dwipe Ablation Systems|
|- 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. |
|- Timepoints||Before esophagectomy, cryoablation will take place and after esophagectomy, the esophagectomy specimen will be analyzed.|
|- Trial web site||none|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||drs. H.T. Künzli|
|- CONTACT for SCIENTIFIC QUERIES||drs. H.T. Künzli|
|- Sponsor/Initiator ||C2 Therapeutics|
(Source(s) of Monetary or Material Support)
|- Publications||Schölvinck DW, Künzli HT, Kestens C, et al. Treatment of Barrett ’ s esophagus with a novel focal cryoablation device : a safety and feasibility study. Endoscopy 2015.|
|- Brief 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. |
|- Main changes (audit trail)|
|- RECORD||31-aug-2015 - 17-okt-2015|