Clinical trial NCT02249975: Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
Official title: Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett's Esophagus
Lead sponsor: Pentax Medical
Sponsor class: INDUSTRY
First posted: 2014-09-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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 ≥ 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.

Primary outcomes:
measure: Presence of residual Barrett's Esophagus
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 12 weeks
measure: Patient Pain
timeFrame: post-procedure through 12 week follow-up
measure: Device Performance
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center Amsterdam
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
Study officials:
affiliation: Academic Medical Centre (Amsterdam)
name: Jacques Bergman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: van Munster SN, Overwater A, Haidry R, Bisschops R, Bergman JJGHM, Weusten BLAM. Focal cryoballoon versus radiofrequency ablation of dysplastic Barrett's esophagus: impact on treatment response and postprocedural pain. Gastrointest Endosc. 2018 Nov;88(5):795-803.e2. doi: 10.1016/j.gie.2018.06.015. Epub 2018 Jun 19.