Clinical trial NCT01293448: Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium
Official title: Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett's Esophagus
Esophageal Cancer
Keywords: Esophagectomy
Barrett's Esophagus
Lead sponsor: Pentax Medical
Sponsor class: INDUSTRY
First posted: 2011-02-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Treatment effect
timeFrame: Within 30 days of ablation procedure
Secondary outcomes:
measure: Post-ablation symptoms
timeFrame: Within 7 days of ablation procedure
measure: Post procedure pain
timeFrame: Within 7 days of ablation procedure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Amsterdam
country: Netherlands
facility: AMC
state: AZ
Study officials:
affiliation: AIDS Malignancy Consortium
name: Jacques Bergman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Steve DeMeester, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Blair Jobe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Jeffery Peters, MD
role: PRINCIPAL_INVESTIGATOR
References: