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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
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SUNNYVALE, Calif., Oct. 19 /PRNewswire/ -- BARRX Medical, Inc. todayannounced clinical trial results presented at the United EuropeanGastroenterology Week (UEGW) in Vienna, Austria, October 18-22, 2008. In aplenary presentation entitled, "Stepwise circumferential and focalradiofrequency energy ablation of Barrett's esophagus with early neoplasia:First European Multi-centre trial" patients with the most advanced stages ofBarrett's esophagus, dysplasia and early cancer, were staged with endoscopicmucosal resection and then treated with the endoscopic radiofrequency ablationusing the HALO Ablation System. After treatment, 96% of patients were cured ofall diseased tissue, with average follow-up exceeding one year.
Population-based studies estimate that Barrett's esophagus affectsapproximately six million European and US adults and is a complication of adisorder called gastroesophageal reflux disease or GERD. Once diagnosed,Barrett's can worsen over time, developing dysplasia and esophagealadenocarcinoma (cancer), as in this study. Once dysplasia or cancer occurs, anesophagectomy (surgical removal of the entire esophagus) has been thefirst-line therapy. Esophageal cancer of this type is the fastest growingcancer in industrialized countries.
Jacques Bergman, M.D., Associate Professor, Department ofGastroenterology, Academic Medical Centre, Amsterdam, the Netherlands, was thesenior investigator for this study. "In several back to back studies now, wehave been successful in using the HALO Ablation System in conjunction withendoscopic resection to cure patients with advanced dysplasia or early cancerof the esophagus," says Dr. Bergman. "Until now, these patients would receivean esophagectomy or more invasive endoscopic therapies, which often haveassociated safety risks. In this study, the complete response rate was quitehigh, over 95%."
In this study, patients with the most advanced stages of Barrett'sesophagus (dysplasia and early cancer) were first staged with endoscopicresection where a large tissue biopsy was obtained to confirm absence ofdeeply invasive cancer. The patient then received ablation using the HALO360Ablation System, a balloon-based ablation device designed to remove thediseased cells using controlled heat. Procedures were performednon-surgically, using endoscopy and sedation, which allowed the patient toreturn to normal activity after the procedure. Patients then underwent focalablation with the HALO90 Ablation System, a smaller device that mounts on theendoscope and is designed to treat small residual areas of Barrett'sesophagus. Patients had endoscopy with biopsy to confirm elimination of thedisease.
The study was conducted at three European centres, including the AcademicMedical Centre, Amsterdam; Evangelisches Krankenhaus, Dusseldorf; and ErasmeUniversity Hospital, Brussels.
About the United European Gastroenterology Week (UEGW)
The UEGW is sponsored by the United European Gastroenterology Federationand is the venue where scientists and clinicians present and learn about thelatest advances in the fields of gastroenterology, endoscopy, hepatology, andgastrointestinal surgery.
About BARRX Medical, Inc.
BARRX Medical, Inc. develops non-surgical, endoscopic treatment solutionsfor Barrett's esophagus. The company's HALO360 Ablation System uses aballoon-based electrode to ablate Barrett tissue circumferentially within theesophagus. The HALO90 Ablation System is an electrode system that is mountedon the end of an endoscope, allowing the physician to treat focal areas ofdiseased tissue. Both HALO Systems provides uniform and controlled therapy ata consistent depth to remove Barrett's esophagus and allow the regrowth ofnormal cells. Both systems are cleared by the U.S. Food and DrugAdministration and have CE Mark in Europe. Based in Sunnyvale, Calif., BARRXMedical, Inc. was founded in 2000 and is a privately held company. Additionalinformation about BARRX Medical, Inc. and the HALO System is available athttp://www.barrx.com.
SOURCE BARRX Medical, Inc.
Jacques Bergman, M.D., Associate Professor, Department ofGastroenterology, Academic Medical Centre, Amsterdam, the Netherlands, was thesenior investigator for this study. "In several back to back studies now, wehave been successful in using the HALO Ablation System in conjunction withendoscopic resection to cure patients with advanced dysplasia or early cancerof the esophagus," says Dr. Bergman. "Until now, these patients would receivean esophagectomy or more invasive endoscopic therapies, which often haveassociated safety risks. In this study, the complete response rate was quitehigh, over 95%."
In this study, patients with the most advanced stages of Barrett'sesophagus (dysplasia and early cancer) were first staged with endoscopicresection where a large tissue biopsy was obtained to confirm absence ofdeeply invasive cancer. The patient then received ablation using the HALO360Ablation System, a balloon-based ablation device designed to remove thediseased cells using controlled heat. Procedures were performednon-surgically, using endoscopy and sedation, which allowed the patient toreturn to normal activity after the procedure. Patients then underwent focalablation with the HALO90 Ablation System, a smaller device that mounts on theendoscope and is designed to treat small residual areas of Barrett'sesophagus. Patients had endoscopy with biopsy to confirm elimination of thedisease.
The study was conducted at three European centres, including the AcademicMedical Centre, Amsterdam; Evangelisches Krankenhaus, Dusseldorf; and ErasmeUniversity Hospital, Brussels.
About the United European Gastroenterology Week (UEGW)
The UEGW is sponsored by the United European Gastroenterology Federationand is the venue where scientists and clinicians present and learn about thelatest advances in the fields of gastroenterology, endoscopy, hepatology, andgastrointestinal surgery.
About BARRX Medical, Inc.
BARRX Medical, Inc. develops non-surgical, endoscopic treatment solutionsfor Barrett's esophagus. The company's HALO360 Ablation System uses aballoon-based electrode to ablate Barrett tissue circumferentially within theesophagus. The HALO90 Ablation System is an electrode system that is mountedon the end of an endoscope, allowing the physician to treat focal areas ofdiseased tissue. Both HALO Systems provides uniform and controlled therapy ata consistent depth to remove Barrett's esophagus and allow the regrowth ofnormal cells. Both systems are cleared by the U.S. Food and DrugAdministration and have CE Mark in Europe. Based in Sunnyvale, Calif., BARRXMedical, Inc. was founded in 2000 and is a privately held company. Additionalinformation about BARRX Medical, Inc. and the HALO System is available athttp://www.barrx.com.
SOURCE BARRX Medical, Inc.
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