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

Barrett's Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01633411
• Other study ID #: CP-0003.A
• Status: Completed
• Start date: December 2011
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• Source: Pentax Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a feasibility study without a primary study hypothesis or statistical comparison.

Description:

The purpose of this study is to assess the safety, feasibility, and performance of the C2 Focal Cryoablation Device in patients with Barrett's Esophagus (BE). At 6 to 8 weeks, the patient will receive a follow-endoscopy to assess stricture formation along with biopsy samples taken. Post-operative pain will be noted. Additionally, 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: - Deployment ease/scope compatibility. - Device malfunctions. - Time of catheter deployment. - Adverse events. - Stricture formation at 6 to 8 weeks. - Patient Pain. - Histological evaluation of treatment zone at 6 to 8 weeks for presence of residual Barrett's Esophagus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 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).

2. Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution's reviewing IRB/EC.

3. Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.

4. Patient is deemed operable per standard institutional criteria.

Exclusion Criteria:

1. Patient with endoscopically active inflammation in the treatment zone

2. Esophageal stenosis preventing advancement of a therapeutic endoscope and/or within 4 cm of treatment zone.

3. 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.

4. Patient refuses or is unable to provide written informed consent.

5. Patients that are pregnant.

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Intervention

Device:
• Focal Cryoballoon Ablation System - 6 seconds
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."
• Focal Cryoballoon Ablation System - 8 seconds
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."
• CryoBalloon Focal Ablation System - 10 seconds
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".

Locations

Country	Name	City	State
Netherlands	Academic Medical Center Amsterdam	Amsterdam
Netherlands	St. Antonius Hospital	Nieuwegein
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
United States	John Hopkins	Baltimore	Maryland
United States	University of Southern California	Los Angeles	California
United States	Columbia Medical Center	New York	New York
United States	Allegheny-Singer Research Institute	Pittsburgh	Pennsylvania
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pentax Medical

Countries where clinical trial is conducted

United States,  Netherlands, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-procedure pain relative	A secondary objective of the study is to determine patient comfort post-procedure. Pain scores are measured on a numerical pain intensity scale (0 to 10). Patients is asked to score pain level in the treatment area and swallowing.	Pre-ablation,12 hrs post ablation, 2 days (+ or - 1 day)
Secondary	Presence of Residual Barrett's Esophagus	Esophageal tissue subjected to ablation via the CryoBalloon Focal Ablation System will be submitted for histological evaluation. The evaluation will include: detailed description of the presence of Barrett's Esophagus and/or squamous mucosa.; estimate of percentage of residual Barrett's in each sample; the detailed description of any residual injury at all levels within the sample.	6 to 8 weeks

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