Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00526786
• Date of registration: 05/09/2007
• Primary sponsor: CSA Medical, Inc.
• Public title: Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus ICE
• Scientific title: A Prospective, Multi-Center, Longitudinal Cohort Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus (LCS Dysplasia)
• Date of first enrolment: September 2007
• Target sample size: 78
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00526786
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Bruce Greenwald, M.D.
• Affiliation: University of Maryland

Key inclusion & exclusion 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.

- Inability to tolerate therapy with a proton pump inhibitor (PPI).

- Refusal or inability to give consent.

- Other active malignancy (except nonmelanoma skin cancer or another cancer for which
patient is deemed disease-free).

- Concurrent chemotherapy.

- Prior radiation therapy which involved the esophagus.

- Prior adenocarcinoma involving the esophagus or stomach.

- Prior or concurrent ablation therapy including, but not limited to, photodynamic
therapy, multipolar electro coagulation, argon plasma coagulation, laser treatment,
radio frequency, etc.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Barrett's Esophagus

High Grade Dysplasia

Low Grade Dysplasia

Intervention(s)

Device: CryoSpray Ablation System (510(k) NO: K070893)

Primary Outcome(s)

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 Outcome(s)

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. [Time Frame: 2 years post treatment]

Secondary ID(s)

16-00016-00

Source(s) of Monetary Support

Please refer to primary and secondary sponsors