Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

NCT01293448 | Completed

• 1 other identifier: CP-0001.A
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Barrett's Esophagus; Esophageal Cancer

Keywords

Esophagectomy; Barrett's Esophagus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Post-ablation symptoms

  Within 7 days of ablation procedure

• Post procedure pain

  Within 7 days of ablation procedure

Study Arms (1)

Intervention

EXPERIMENTAL

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

Device: Cryoballoon Ablation

Interventions

Cryoballoon Ablation 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)

Also known as: CryoBalloon Ablation System, cryoablation

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pentax Medical: lead

Study Sites (4)

University of Southern California

Los Angeles, California, 90033, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

Location

AMC

Amsterdam, AZ, 1105, Netherlands

Location

MeSH Terms

Conditions

Barrett Esophagus; Esophageal Neoplasms

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: February 10, 2011
• Study Start: December 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 28, 2022

Record last verified: 2018-01

Locations

US (3); NL (1)