A Prospective, Multi-center, Longitudinal Cohort Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus (LCS Dysplasia)

CSA Medical, Inc.16 sites in 1 country78 target enrollmentSeptember 2007

ConditionsBarrett's Esophagus High Grade Dysplasia Low Grade Dysplasia

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Barrett's Esophagus
Sponsor: CSA Medical, Inc.
Enrollment: 78
Locations: 16
Primary Endpoint: The eradication of LGD and HGD within BE at 24 months after the final treatment. The primary safety endpoint is the incidence of all adverse events.
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the CryoSpray Ablation System to treat esophageal low grade dysplasia (LGD) or high grade dysplasia (HGD) within Barrett's Esophagus (BE).

Detailed Description

The study will consist of an estimated 200 subjects with HGD or LGD within BE who are deemed inoperable or refuse standard surgical treatment. A maximum of 20 investigational sites will participate with a maximum of ten subjects per site.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

September 2009

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CSA Medical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Karnofsky performance status of 50-100%
•Life expectancy greater than 5 years
•Hematopoietic, Hepatic and Renal lab clearance
•Previous endoscopy with histological confirmation of LGD or HGD within BE
•For Group 2, deemed inoperable based on the following criteria: co-morbid conditions such as severe heart, lung, kidney or liver disease; or refusal of surgical intervention after a thorough unbiased discussion of surgery.
•For Group 2, endoscopic ultrasound (EUS) evaluation demonstrating no evidence of invasion or metastatic lymph node involvement (T0N0M0 by EUS).

Exclusion Criteria

•Pregnant, not practicing adequate contraception, intending to become pregnant, or lactating at any time during the study (approximately 2 years).
•Esophageal stricture preventing passage of endoscope or catheter.
•Active esophagitis
•EMR performed less than 8 weeks prior to CSA treatment.
•EMR performed on greater than 90% circumference of any area of the esophagus.
•Any previous esophageal surgery, except fundoplication without complications.
•Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines.
•Concurrent enrollment in an investigational drug or device trial that clinically interferes with the LCS Dysplasia endpoints.
•Psychiatric or other illness deemed by the investigator as an inability to comply with this protocol.
•Medically unfit or other contraindication to tolerate upper endoscopy.

Outcomes

Primary Outcomes

The eradication of LGD and HGD within BE at 24 months after the final treatment. The primary safety endpoint is the incidence of all adverse events.

Time Frame: 2 years post treatment

Secondary Outcomes

1.Eradication of all BE by 24 months after the final treatment. 2.The proportion of lesions that decreased in length by the 24-month follow-up. 3.The proportion of lesions where severity was downgraded by the 24-month follow-up.(2 years post treatment)