clinical-results

Clinical Results

Radiofrequency ablation (RFA) has been studied in many clinical trials since 2003 in the United States and Europe. Results have been published in over 40 articles in peer-reviewed medical journals such as The New England Journal of Medicine. Outcomes have shown that RFA is safe and effective for treating all types of Barrett's tissue. Most demonstrate that Barrett's tissue can be completely eliminated with RFA in greater than 98% of patients who receive treatment.

Over 1,000 physicians have performed over 60,000 RFA procedures. In the largest patient cohort available to date, the U.S. HALO Patient Registry, approximately 50% of patients have non-dysplastic Barrett's esophagus, indicating a trend toward earlier intervention among physicians utilizing this therapy.

Clinical findings

Examples of key clinical findings include20, 21, 22, 28, 29, 30:

  • Complete clearance of non-dysplastic Barrett's esophagus in 98.4% of patients at two and a half year follow-up. 7
  • Outstanding safety profile with a less than or equal to 6% stricture rate**, less than 0.02% perforation rate, and no associated deaths.14 (Based on safety data through June 2010.)
  • Overall, complete eradication of non-dysplastic and dysplastic Barrett's esophagus at rates exceeding 90% has been shown in numerous studies.
  • Elimination of abnormal genetic markers associated with Barrett's esophagus after RFA therapy.
  • No change in the function of the esophagus after RFA therapy.

* Important Reminder: This information is not intended as a definitive basis for diagnosis or treatment in any particular case. It is very important that you consult your doctor about your specific condition, contraindications, and possible complications.

** Data is based on RFA performed according to manufacturer's instructions.


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