Menorrhagia Clinical Trial
Official title:
A Study to Evaluate the Effectiveness of Extended Treatment Regimens With the Her Option® Cryoablation Therapy System for Treatment of Menorrhagia
The Her Option® Cryoablation Therapy System is a closed-loop cryosurgical device that is
used to ablate the endometrial lining in pre-menopausal women with menorrhagia (excessive
menstrual bleeding) due to benign causes. This is a non-incisional procedure, which can be
performed in a physicians office with minimal sedation.
Initial FDA clinical studies were conducted with a two-freeze treatment pattern consisting
of a 4 minute freeze with the Cryoprobe positioned in one cornu followed by a second freeze
of 6 minutes with the Cryoprobe repositioned in the contralateral cornu.
Since completion of the early studies, many physicians have experimented with varying freeze
patterns using longer freeze durations and/or additional freezes at the fundus and the lower
uterine segment. The results, as reported in the literature, indicate that these extended
freeze patterns produce significantly better results than the original regimen.
American Medical Systems, Inc. (AMS) hypothesized that the original treatment pattern used to support a previous FDA approval for the Her Option® Cryoablation Therapy System for Treatment of abnormal uterine bleeding was not optimal and that extended freeze regimens will result in improved outcomes for patients. ;
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