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

NCT02249975 | Completed

• 1 other identifier: CP-0004.A
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Barrett's Esophagus

Outcome Measures

Primary Outcomes (1)

• Presence of residual Barrett's Esophagus

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

  12 weeks

Secondary Outcomes (3)

• Incidence of adverse events

  12 weeks

• Patient Pain

  post-procedure through 12 week follow-up

• Device Performance

  12 weeks

Study Arms (1)

C2 CryoBalloon Focal Ablation System

EXPERIMENTAL

Cryoballoon ablation will be performed on patients with Barrett's Esophagus.

Device: C2 CryoBalloon Focal Ablation System

Interventions

C2 CryoBalloon Focal Ablation System DEVICE

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.

C2 CryoBalloon Focal Ablation System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pentax Medical: lead

Study Sites (2)

Academic Medical Center Amsterdam

Amsterdam, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 21531411 RESULT

• 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.

  PMID: 29928869 DERIVED

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jacques Bergman, MD, PhD

  Academic Medical Centre (Amsterdam)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: September 26, 2014
• Study Start: January 1, 2015
• Primary Completion: December 29, 2016
• Study Completion: October 4, 2017
• Last Updated: April 28, 2022

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)