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Novasure compared with rollerball: automated ablation shows long-term efficacy.(News)
PHILADELPHIA -- An automated device for endometrial ablation was as safe and effective as conventional ablation with a rollerball during 3 years of follow-up in a controlled study with 265 patients.
The automated system, marketed as NovaSure, was faster than conventional ablation and did not require pretreatment with wire loop resection, Dr. Richard J. Gimpelson said at the annual meeting of the American College of Obstetricians and Gynecologists.
The NovaSure system can be used in a physician's office using local anesthesia and sedation. The rollerball method was usually used in a clinic or hospital, and was usually done using general anesthesia.
NovaSure has been available in the United States since the start of 2002. The device is marketed by Novacept, which sponsored the study. Dr. Gimpelson is on the speakers' bureau of Novacept and also teaches physicians who are learning to use the automated device. He formerly owned Novacept stock.
Dr. Gimpelson and associates followed the patients who were enrolled in the phase III, pivotal trial of NovaSure for up to 3 years. The 1-year results from this study were the basis for the Food and Drug Administration's approval of the device in 2001. The study was done at nine centers in the United States, Canada, and Mexico.
Women who enrolled in the study had dysfunctional uterine bleeding, and were 25-50 years old and premenopausal. Their maximal uterine length was 10 cm, and they had a bleeding score of at least 150. Bleeding score was calculated as the cumulative number of points during 4 consecutive days, with 20 points scored for each saturated pad used, and 10 points for a partially saturated pad. The actual mean score of the women enrolled was 500, and their mean age was about 40 years old. They were randomized to treatment with either NovaSure or rollerball treatment using hysteroscopy on a 2:1 basis.
Local anesthesia and sedation were used on 73% of the women treated with NovaSure and 18% of women who were treated with a ...
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Source: HighBeam Research, Novasure compared with rollerball: automated ablation shows long-term...