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Completed

NCT Number: NCT02249975

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

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

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Key information

Conditions

Barrett's Esophagus Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Medical Center Amsterdam, Amsterdam, Netherlands

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Presence of residual Barrett's Esophagus

    Time frame: 12 weeks

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

Secondary outcomes

  1. Incidence of adverse events

    Time frame: 12 weeks

    All adverse events will be reported

  2. Patient Pain

    Time frame: post-procedure through 12 week follow-up

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

  3. Device Performance

    Time frame: 12 weeks

    All device performance will be reported

Sponsors and collaborators

Lead sponsor

Pentax Medical

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Sep 26, 2014
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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