Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

• ClinicalTrials.gov Identifier: NCT01293448
• Recruitment Status: Completed
• First Posted: February 10, 2011
• Last Update Posted: April 28, 2022
• Sponsor: Pentax Medical
• Information provided by (Responsible Party): Pentax Medical

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Barrett's Esophagus; Esophageal Cancer	Device: Cryoballoon Ablation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium
• Study Start Date: December 2010
• Actual Primary Completion Date: January 2012
• Actual Study Completion Date: January 2012

Arms and Interventions

Arm

Intervention/treatment

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

Device: 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); Other Names: CryoBalloon Ablation System; cryoablation

Outcome Measures

Primary Outcome Measures :

1. Treatment effect [ Time Frame: 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 :

1. Post-ablation symptoms [ Time Frame: 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.
2. Post procedure pain [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

United States, California

University of Southern California

Los Angeles, California, United States, 90033

United States, New York

University of Rochester

Rochester, New York, United States, 14642

United States, Pennsylvania

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15232

Netherlands

AMC

Amsterdam, AZ, Netherlands, 1105

Sponsors and Collaborators

Pentax Medical

Investigators

• Principal Investigator: Jacques Bergman, MD; AIDS Malignancy Consortium
• Principal Investigator: Steve DeMeester, MD; University of Southern California
• Principal Investigator: Blair Jobe, MD; University of Pittsburgh
• Principal Investigator: Jeffery Peters, MD; University of Rochester

More Information

• Responsible Party: Pentax Medical
• ClinicalTrials.gov Identifier: NCT01293448
• Other Study ID Numbers: CP-0001.A
• First Posted: February 10, 2011
• Last Update Posted: April 28, 2022
• Last Verified: January 2018

Keywords provided by Pentax Medical:

Esophagectomy; Barrett's Esophagus

Additional relevant MeSH terms:

Barrett Esophagus; Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Precancerous Conditions