Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
1 other identifier
observational
39
2 countries
8
Brief Summary
This is a feasibility study without a primary study hypothesis or statistical comparison.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2011
Typical duration for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 28, 2012
CompletedFirst Posted
Study publicly available on registry
July 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedApril 28, 2022
April 1, 2015
2.4 years
June 28, 2012
April 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Esophageal Stricture
Stricture formation is defined as none, mild (non-circumferential stenosis allowing easy passage of diagnostic endoscope), moderate (circular stenosis allowing passage of diagnostic endoscope), and severe (any stenosis preventing the passage of a diagnostic scope).
6 to 8 Weeks
Secondary Outcomes (2)
Post-procedure pain relative
Pre-ablation,12 hrs post ablation, 2 days (+ or - 1 day)
Presence of Residual Barrett's Esophagus
6 to 8 weeks
Study Arms (3)
Cohort A
Subjects in Cohort A will receive 6 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.
Cohort B
Subjects in Cohort B will receive 8 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.
Cohort C
Subjects in Cohort C will receive 10 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.
Interventions
Ablation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications."
Ablation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications."
Ablation of Barrett's Esophagus using the Focal CryoBalloon Ablation System. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications".
Eligibility Criteria
Patients with Barrett's esophagus with or without dysplasia
You may qualify if:
- Patients scheduled for ablation, EMR, and/or surveillance for BE (with or without dysplasia). 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.
You may not qualify if:
- Patient with endoscopically active inflammation in the treatment zone
- Esophageal stenosis preventing advancement of a therapeutic endoscope and/or 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pentax Medicallead
Study Sites (8)
University of Southern California
Los Angeles, California, 90033, United States
John Hopkins
Baltimore, Maryland, 21205, United States
Columbia Medical Center
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14642, United States
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15212, United States
Academic Medical Center Amsterdam
Amsterdam, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Related 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.
PMID: 21531411BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bas L Weusten, MD, pHD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2012
First Posted
July 4, 2012
Study Start
December 1, 2011
Primary Completion
May 1, 2014
Study Completion
June 1, 2014
Last Updated
April 28, 2022
Record last verified: 2015-04