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

Pentax Medical

Status: Completed

Conditions: Barrett's Esophagus

Treatments: Device: CryoBalloon Focal Ablation System - 10 seconds; Device: Focal Cryoballoon Ablation System - 8 seconds; Device: Focal Cryoballoon Ablation System - 6 seconds

Study type: Observational

Funder types: Industry

Identifiers

NCT01633411

CP-0003.A

Details and patient eligibility

About

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

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

39 participants in 3 patient groups

Cohort A

Description:

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

Treatment:

Device: Focal Cryoballoon Ablation System - 6 seconds

Cohort B

Description:

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

Treatment:

Device: Focal Cryoballoon Ablation System - 8 seconds

Cohort C

Description:

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

Treatment:

Device: CryoBalloon Focal Ablation System - 10 seconds