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Clinical study to Evaluate the Coldplay CryoBalloonTM Full and Swipe Ablation Systems for the Ablation of Human Esophageal Epithelium in Patients Undergoing Esophagectomy


- candidate number22816
- NTR NumberNTR5394
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-aug-2015
- Secondary IDsNL53312.018.15 METC 2015_130
- Public TitleClinical study to Evaluate the Coldplay CryoBalloonTM Full and Swipe Ablation Systems for the Ablation of Human Esophageal Epithelium in Patients Undergoing Esophagectomy
- Scientific TitleClinical study to Evaluate the Coldplay CryoBalloonTM Full and Swipe Ablation Systems for the Ablation of Human Esophageal Epithelium in Patients Undergoing Esophagectomy
- ACRONYMECCAS-study
- hypothesisThe 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) studiedBarrett's esophagus, Cryoablation
- Inclusion criteriaPatients 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 criteriaPatients 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 receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-okt-2015
- planned closingdate1-mrt-2016
- Target number of participants5
- Interventionscryoablation using the Cryoballoon Full and Dwipe Ablation Systems
- Primary outcomesafety 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 outcomeThe secondary outcome is device performance: ease of deployment, procedure time, endoscope compatibility, and device malfunction.
- TimepointsBefore esophagectomy, cryoablation will take place and after esophagectomy, the esophagectomy specimen will be analyzed.
- Trial web sitenone
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESdrs. H.T. Künzli
- CONTACT for SCIENTIFIC QUERIESdrs. H.T. Künzli
- Sponsor/Initiator C2 Therapeutics
- Funding
(Source(s) of Monetary or Material Support)
C2 Therapeutics
- PublicationsSchölvinck 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 summaryThe 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)
- RECORD31-aug-2015 - 17-okt-2015


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