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

• Sponsor: Pentax Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02249975
• Collaborator: (none)
• Enrollment: 50
• Locations: 2
• Arm: 1
• Duration (Months): 33.1
• Patients Per Site: 25
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Barrett's Esophagus	Device: C2 CryoBalloon Focal Ablation System	N/A

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
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Dec 29, 2016
• Actual Study Completion Date: Oct 4, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: C2 CryoBalloon Focal Ablation System Cryoballoon ablation will be performed on patients with Barrett's Esophagus.

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.

Outcome Measures

Primary Outcome Measures

1. Presence of residual Barrett's Esophagus [12 weeks]

   Efficacy (% of) Barrett's epithelium fully converted to squamous epithelium upon cryoablation

Secondary Outcome Measures

1. Incidence of adverse events [12 weeks]

   All adverse events will be reported

2. Patient Pain [post-procedure through 12 week follow-up]

   Patient is asked to rate any pain in the treatment area or with swallowing

3. Device Performance [12 weeks]

   All device performance will be reported

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Academic Medical Center Amsterdam	Amsterdam		Netherlands
2	St. Antonius Hospital	Nieuwegein		Netherlands

Sponsors and Collaborators

• Pentax Medical

Investigators

• Principal Investigator: Jacques Bergman, MD, PhD, Academic Medical Centre (Amsterdam)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pentax Medical
• ClinicalTrials.gov Identifier: NCT02249975
• Other Study ID Numbers: CP-0004.A
• First Posted: Sep 26, 2014
• Last Update Posted: Apr 28, 2022
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Barrett Esophagus

Study Results

No Results Posted as of Apr 28, 2022