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

Completed

• Conditions: Barrett's Esophagus
• Interventions: Device: Focal Cryoballoon Ablation System - 6 seconds; Device: Focal Cryoballoon Ablation System - 8 seconds; Device: CryoBalloon Focal Ablation System - 10 seconds

• Registration Number: NCT01633411
• Lead Sponsor: Pentax Medical

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2012-06-29
• Study First Posted: 2012-07-04
• Primary Completion: 2014-05
• Study Completion: 2014-06
• Status Verified: 2015-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort A	Focal Cryoballoon Ablation System - 6 seconds	Subjects in Cohort A will receive 6 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.
Cohort B	Focal Cryoballoon Ablation System - 8 seconds	Subjects in Cohort B will receive 8 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.
Cohort C	CryoBalloon Focal Ablation System - 10 seconds	Subjects in Cohort C will receive 10 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.

Primary Outcome Measures

Name	Time	Method
Esophageal Stricture	6 to 8 Weeks	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).

Secondary Outcome Measures

Name	Time	Method
Post-procedure pain relative	Pre-ablation,12 hrs post ablation, 2 days (+ or - 1 day)	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.
Presence of Residual Barrett's Esophagus	6 to 8 weeks	Esophageal tissue subjected to ablation via the CryoBalloon Focal Ablation System will be submitted for histological evaluation. The evaluation will include: 1. detailed description of the presence of Barrett's Esophagus and/or squamous mucosa.; 2. estimate of percentage of residual Barrett's in each sample; 3. the detailed description of any residual injury at all levels within the sample.

Trial Locations

Locations (8)

Academic Medical Center Amsterdam; 🇳🇱 Amsterdam, Netherlands

Columbia Medical Center; 🇺🇸 New York, New York, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

St. Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands

John Hopkins; 🇺🇸 Baltimore, Maryland, United States

Universitair Medisch Centrum Utrecht; 🇳🇱 Utrecht, Netherlands

Allegheny-Singer Research Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States