A prospective, multicenter clinical trial to evaluate the safety and the effectiveness of the AEGEA Vapor System* for the treatment of excessive uterine bleeding. - Pivotal study

AEGEA Medical Inc.0 sites18 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

July 16, 2018

Last Updated

2 years ago

Study Type

Interventional

Sponsor

AEGEA Medical Inc.

•1\. Able to understand and has voluntarily signed and dated the IRB/EC approved informed
•consent form (ICF) prior to initiation of any screening or study\-specific procedures;
•2\. Female subject from (and including) age 30 to 50 years;
•3\. Self\-reported history of heavy menstrual bleeding in at least 3 of the last 6 months prior to
•4\. Predictable cyclic menstrual cycles (consistent cycle duration days 21\-35 days) over the
•last 6 months;
•5\. Excessive uterine bleeding, as documented by the Pictorial Blood Loss Assessment
•Chart (PBLAC), with a PBLAC score of \*150 for one baseline cycle within three months
•prior to the endometrial ablation procedure for women who:
•\* Had at least 3 prior months (documented) failed medical therapy; or

•1\. Is pregnant as determined by urine or serum pregnancy test at screening or on day of
•2\. Desires future childbearing;
•3\. Presence of an intrauterine device/system (IUD/IUS) that the subject is unwilling to have
•removed prior to or at the time of the ablation procedure. Note: Subjects using a
•hormonal releasing IUD/IUS must have their device removed prior to ablation and then
•have one complete menstrual cycle at which time the baseline PBLAC diary may be
•completed. An IUD/IUS may not be re\-inserted following ablation. The subject must
•agree to rely on either a barrier method plus spermicide, or vasectomy through the initial
•12 month follow\-up phase, as outlined above in inclusion (9\).
•4\. Previous endometrial ablation procedure;