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gblyth
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Joined: 19 Apr 2007
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Quote gblyth Replybullet Topic: Clincal Trial Results for the Halo System
    Posted: 31 Oct 2008 at 10:57pm
MULTI-CENTRE EUROPEAN CLINICAL TRIAL SHOWS ADVANCED DYSPLASIA AND EARLY CANCER OF ESOPHAGUS CURED WITH COMBINED ENDOSCOPIC RESECTION AND RADIOFREQUENCY ABLATION WITH HALO ABLATION SYSTEM
Pharma
BARRX Medical, Inc.
20/10/2008
 
- Non-surgical intervention cures 96% of patients with advanced esophagus condition.

BARRX Medical, Inc. today announced clinical trial results presented at the United European Gastroenterology Week (UEGW) in Vienna, Austria, October 18-22, 2008. In a plenary presentation entitled, "Stepwise circumferential and focal radiofrequency energy ablation of Barrett's esophagus with early neoplasia: First European Multi-centre trial" patients with the most advanced stages of Barrett's esophagus, dysplasia and early cancer, were staged with endoscopic mucosal resection and then treated with the endoscopic radiofrequency ablation using the HALO Ablation System. After treatment, 96% of patients were cured of all diseased tissue, with average follow-up exceeding one year.

Population-based studies estimate that Barrett's esophagus affects approximately six million European and US adults and is a complication of a disorder called gastroesophageal reflux disease or GERD. Once diagnosed, Barrett's can worsen over time, developing dysplasia and esophageal adenocarcinoma (cancer), as in this study. Once dysplasia or cancer occurs, an esophagectomy (surgical removal of the entire esophagus) has been the first-line therapy. Esophageal cancer of this type is the fastest growing cancer in industrialized countries.

Jacques Bergman, M.D., Associate Professor, Department of Gastroenterology, Academic Medical Centre, Amsterdam, the Netherlands, was the senior investigator for this study. "In several back to back studies now, we have been successful in using the HALO Ablation System in conjunction with endoscopic resection to cure patients with advanced dysplasia or early cancer of the esophagus," says Dr. Bergman. "Until now, these patients would receive an esophagectomy or more invasive endoscopic therapies, which often have associated safety risks. In this study, the complete response rate was quite high, over 95%."

In this study, patients with the most advanced stages of Barrett's esophagus (dysplasia and early cancer) were first staged with endoscopic resection where a large tissue biopsy was obtained to confirm absence of deeply invasive cancer. The patient then received ablation using the HALO360 Ablation System, a balloon-based ablation device designed to remove the diseased cells using controlled heat. Procedures were performed non-surgically, using endoscopy and sedation, which allowed the patient to return to normal activity after the procedure. Patients then underwent focal ablation with the HALO90 Ablation System, a smaller device that mounts on the endoscope and is designed to treat small residual areas of Barrett's esophagus. Patients had endoscopy with biopsy to confirm elimination of the disease.

The study was conducted at three European centres, including the Academic Medical Centre, Amsterdam; Evangelisches Krankenhaus, Dusseldorf; and Erasme University Hospital, Brussels.

Please note that trials are also now starting in the UK.




Edited by gblyth - 31 Oct 2008 at 11:06pm
I would like to declare that I am a director of SynMed Limited the company that distributes the Halo Treatment from Barrx Medical in the UK.

Geoffrey Blyth




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