Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
- Conditions
- Barrett's Esophagus
- Registration Number
- NCT02249975
- Lead Sponsor
- Pentax Medical
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Presence of residual Barrett's Esophagus 12 weeks Efficacy (% of) Barrett's epithelium fully converted to squamous epithelium upon cryoablation
- Secondary Outcome Measures
Name Time Method Patient Pain post-procedure through 12 week follow-up Patient is asked to rate any pain in the treatment area or with swallowing
Device Performance 12 weeks All device performance will be reported
Incidence of adverse events 12 weeks All adverse events will be reported
Trial Locations
- Locations (2)
Academic Medical Center Amsterdam
🇳🇱Amsterdam, Netherlands
St. Antonius Hospital
🇳🇱Nieuwegein, Netherlands
Academic Medical Center Amsterdam🇳🇱Amsterdam, Netherlands