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Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium


Phase 1
18 Years
80 Years
Open (Enrolling)
Both
Barrett's Esophagus, Esophageal Cancer

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Trial Information

Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium


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.


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).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Treatment effect

Outcome Description:

The primary outcome measure is to evaluate the histological results (depth of injury) of a cryoballoon ablation system.

Outcome Time Frame:

Within 30 days of ablation procedure

Safety Issue:

No

Principal Investigator

Jacques Bergman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

AIDS Malignancy Clinical Trials Consortium

Authority:

United States: Institutional Review Board

Study ID:

CP-0001.A

NCT ID:

NCT01293448

Start Date:

January 2011

Completion Date:

June 2013

Related Keywords:

  • Barrett's Esophagus
  • Esophageal Cancer
  • Esophagectomy
  • Barrett's Esophagus
  • Barrett Esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

University of PittsburghPittsburgh, Pennsylvania  15261
University of RochesterRochester, New York  14642
University of Southern CaliforniaLos Angeles, California  90033