Status:
COMPLETED
Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
Lead Sponsor:
Pentax Medical
Conditions:
Barrett's Esophagus
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE.
Detailed Description
The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE. The study will involve up to 50 subjects with each subject receiving cryoab...
Eligibility Criteria
Inclusion
- Criteria Inclusion Criteria
- Patients with known Barrett's esophagus, with an indication for ablation therapy during which the cryoablation may be performed.
- Patient is 18 to 80 years of age at the time of consent (inclusive).
- Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution's reviewing IRB/EC.
- Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
- Patient is deemed operable per standard institutional criteria.
- BE lesion length \<6cm excluding visible BE islands, and Prague Classification C ≥ 0 / M ≥ 0.
- One of the following: Flat LGD, Flat HGD, Residual BE after EMR for visible lesions (containing any degree of dysplasia or low-risk early adenocarcinoma (i.e.: not poorly differentiated, negative vertical (deep) resection margins, absence of (lympho)vascular invasion), Residual BE after a single circumferential RFA (performed for indications listed above: i-iii)
- BE lesion within the treatment zone should be flat
- Exclusion Criteria
- Esophageal stenosis preventing advancement of a therapeutic endoscope within 4 cm of treatment zone.
- Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post treatment instructions or follow-up guidelines.
- Patient refuses or is unable to provide written informed consent.
- Patients that are pregnant.
- Patient with endoscopically active inflammation in the treatment zone.
- Endoscopically visible abnormalities such as masses or nodules requiring endoscopic resection.
Exclusion
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02249975
Start Date
January 1 2015
End Date
October 4 2017
Last Update
April 28 2022
Active Locations (2)
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1
Academic Medical Center Amsterdam
Amsterdam, Netherlands
2
St. Antonius Hospital
Nieuwegein, Netherlands