Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

Barrett's Esophagus Clinical Trial

Official title:

Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02249975
• Other study ID #: CP-0004.A
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: October 4, 2017

Study information

• Verified date: February 2018
• Source: Pentax Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 4, 2017
• Est. primary completion date: December 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Intervention

Device:
• C2 CryoBalloon Focal Ablation System
The C2 Focal Cryoablation Device will be used for the treatment of islands of BE in real patient care. Ablation at 10 seconds will be tested and post-ablation symptoms related to the Cryoballoon Focal Ablation will be recorded. At 12 weeks, the patient will receive a follow-up endoscopy and biopsy samples will be taken. Biopsy samples will be evaluated for the presence of residual Barrett's Esophagus. Through evaluation of the histological results, treatment parameters for the ablation of human esophageal epithelium will be better understood. Evaluations include, but are not limited to the following: Device malfunctions Adverse events Patient Pain Histological evaluation of treatment zone at 12 weeks for presence of residual Barrett's Esophagus.

Locations

Country	Name	City	State
Netherlands	Academic Medical Center Amsterdam	Amsterdam
Netherlands	St. Antonius Hospital	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
Pentax Medical

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Friedland S, Triadafilopoulos G. A novel device for ablation of abnormal esophageal mucosa (with video). Gastrointest Endosc. 2011 Jul;74(1):182-8. doi: 10.1016/j.gie.2011.03.1119. Epub 2011 Apr 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of residual Barrett's Esophagus	Efficacy (% of) Barrett's epithelium fully converted to squamous epithelium upon cryoablation	12 weeks
Secondary	Incidence of adverse events	All adverse events will be reported	12 weeks
Secondary	Patient Pain	Patient is asked to rate any pain in the treatment area or with swallowing	post-procedure through 12 week follow-up
Secondary	Device Performance	All device performance will be reported	12 weeks