Study of CryoSpray Ablation(TM)to Determine Treatment Effect, Depth of Injury, and Side Effects in the Esophagus.

Completed · Phase 4

Conditions studied: Barrett's Esophagus, Esophageal Cancer

In brief

The purpose of this study is to evaluate the treatment effect, depth of injury, and side effects using technology involving the spray of liquid nitrogen through a catheter (CryoSpray AblationTM, "CSA" or "cryospray therapy") onto healthy tissue via esophagogastroduodenoscopy (EGD) using surgical resection specimens from subjects undergoing esophagectomy.

Key facts

Study ID

NCT00754468

Run by

CSA Medical, Inc.

People needed

7

Starts

2009-02-01

Expected to finish

2012-03-01

Last updated by the study team

2015-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years of age
• Esophagectomy planned based on clinical situation not related to this study.
• Deemed operable based on institutional criteria.

You may not qualify if…

• Pregnant
• Esophageal stricture preventing passage of endoscope or catheter.
• 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.
• Refusal or inability to give consent.
• Concurrent chemotherapy.
• Prior or concurrent endoscopic ablation therapy within 4 cm from the CSA 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.
• Prior radiation therapy which involved the esophagus.

Where it is running

• University of Miami, Sylvester Comprehensive Cancer Center — Miami, Florida, United States

Full record on ClinicalTrials.gov

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