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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Barrett's Esophagus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort A

Subjects in Cohort A will receive 6 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.

Focal Cryoballoon Ablation System - 6 seconds

Intervention Type DEVICE

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."

Cohort B

Subjects in Cohort B will receive 8 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.

Focal Cryoballoon Ablation System - 8 seconds

Intervention Type DEVICE

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."

Cohort C

Subjects in Cohort C will receive 10 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.

CryoBalloon Focal Ablation System - 10 seconds

Intervention Type DEVICE

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".

Interventions

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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."

Intervention Type DEVICE

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."

Intervention Type DEVICE

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".

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No