Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

Esophageal Cancer Clinical Trial

Official title:

Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293448
• Other study ID #: CP-0001.A
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: January 2012

Study information

• Verified date: January 2018
• Source: Pentax Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• Esophageal Cancer

Intervention

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)

Locations

Country	Name	City	State
Netherlands	AMC	Amsterdam	AZ
United States	University of Southern California	Los Angeles	California
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pentax Medical

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment effect	The primary outcome measure is to evaluate the histological results (depth of injury) of a cryoballoon ablation system.	Within 30 days of ablation procedure
Secondary	Post-ablation symptoms	A secondary outcome measure is to evaluate post-ablation symptoms - number of participants with adverse events as a measure of safety and tolerability.	Within 7 days of ablation procedure
Secondary	Post procedure pain	The secondary objective of the study is to determine patient comfort post-procedure. Pain scores are measured on a numerical pain intensity scale.	Within 7 days of ablation procedure