Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pentax Medical
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Presence of residual Barrett's Esophagus
Study Overview
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 cryoablation therapy of all visible BE using the C2 System Focal Ablation System. Length of ablation will be 10 seconds. The ablations will be performed on Barrett's epithelium with a maximal length of 6 cm.
At the time of endoscopic follow up, biopsies of the treated area will be taken and submitted for analysis according to Histopathology Protocol.
This study is:
- Prospective
- Multi-center
- Non-randomized
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 ≥
- •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.
Arms & Interventions
C2 CryoBalloon Focal Ablation System
Cryoballoon ablation will be performed on patients with Barrett's Esophagus.
Intervention: C2 CryoBalloon Focal Ablation System (Device)
Outcomes
Primary Outcomes
Presence of residual Barrett's Esophagus
Time Frame: 12 weeks
Efficacy (% of) Barrett's epithelium fully converted to squamous epithelium upon cryoablation
Secondary Outcomes
- Patient Pain(post-procedure through 12 week follow-up)
- Device Performance(12 weeks)
- Incidence of adverse events(12 weeks)