Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

Not Applicable

Completed

• Conditions: Esophageal Cancer; Barrett's Esophagus
• Interventions: Device: Cryoballoon Ablation

• Registration Number: NCT01293448
• Lead Sponsor: Pentax Medical

Brief Summary

The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.

Detailed Description

The purpose of this study is to evaluate the histological results of a cryoablation technique used to ablate human esophageal mucosa. The performance and safety of the cryoablation technique will also be evaluated.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-14
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-10
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2018-01
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Patient must have a minimum of 2.0 cm of non-ulcerated, non-inflammatory columnar-lined esophagus or squamous esophageal lined tissue suitable for ablation. A patient may be treated with up to 2 zones of ablation.
• Patient is 18 to 80 years of age at the time of consent (inclusive).
• Patient has provided written Informed Consent Form (IFC) using a form 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's esophagectomy is clinically necessary due to reasons unrelated to this study.
• Patient is deemed operable per standard institutional criteria.

Exclusion Criteria

• Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to IFC, post treatment instructions or follow-up guidelines.
• Patient refuses or is unable to provide written informed consent. - -
• Patient has or is currently undergoing endoscopic ablation therapy within 4 cm from the proposed treatment area including, but not limited to cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
• Patient has esophageal narrowing limiting access to the intended site of ablation.
• Patient is undergoing or has recently undergone chemotherapy (within 15 days or WBC below normal by institutional criteria or standards).
• Patient is undergoing or has recently undergone radiation therapy which involved the esophagus (within 15 days or WBC below normal by institutional criteria or standards).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Cryoballoon Ablation	CryoBalloon ablation of esophageal tissue in patients scheduled for esophagectomy for reasons unrelated to the objective of the study.

Primary Outcome Measures

Name	Time	Method
Treatment effect	Within 30 days of ablation procedure	The primary outcome measure is to evaluate the histological results (depth of injury) of a cryoballoon ablation system.

Secondary Outcome Measures

Name	Time	Method
Post-ablation symptoms	Within 7 days of ablation procedure	A secondary outcome measure is to evaluate post-ablation symptoms - number of participants with adverse events as a measure of safety and tolerability.
Post procedure pain	Within 7 days of ablation procedure	The secondary objective of the study is to determine patient comfort post-procedure. Pain scores are measured on a numerical pain intensity scale.

Trial Locations

Locations (4)

AMC; 🇳🇱 Amsterdam, AZ, Netherlands

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

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

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States