Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

NCT ID: NCT01293448

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-01-31

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.

Conditions

Barrett's Esophagus; Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

CryoBalloon ablation of esophageal tissue in patients scheduled for esophagectomy for reasons unrelated to the objective of the study.

Group Type: EXPERIMENTAL

Cryoballoon Ablation

Intervention Type: DEVICE

Device: CryoBalloon Ablation System(TM) C2 Therapeutics Inc. received FDA market clearance for the CryoBalloon Ablation System on September 29, 2010. 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." (K101825)

Interventions

Cryoballoon Ablation

Device: CryoBalloon Ablation System(TM) C2 Therapeutics Inc. received FDA market clearance for the CryoBalloon Ablation System on September 29, 2010. 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." (K101825)

Intervention Type: DEVICE

Other Intervention Names

CryoBalloon Ablation System; cryoablation

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pentax Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Bergman, MD

Role: PRINCIPAL_INVESTIGATOR

AIDS Malignancy Consortium

Steve DeMeester, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Blair Jobe, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Jeffery Peters, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Southern California

Los Angeles, California, United States

University of Rochester

Rochester, New York, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

AMC

Amsterdam, AZ, Netherlands

Countries

United States; Netherlands

Other Identifiers

CP-0001.A

Identifier Type: -

Identifier Source: org_study_id