Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB)

This is a prospective, multicenter, single-arm interventional feasibility study to evaluate the safety and feasibility of the Juveena Hydrogel System for temporary control of heavy menstrual bleeding (HMB) in women with a history of chronic ovulatory HMB.

This is a prospective, multicenter, single-arm interventional feasibility study to evaluate the safety and feasibility of the Juveena Hydrogel System (HS) for temporary control of heavy menstrual bleeding (HMB) in women with a history of chronic ovulatory HMB. Consenting subjects will be screened for eligibility and will have a baseline evaluation, including medical and gynecological history, and characterization of their menstrual cycle. Eligible subjects will be tentatively scheduled for Juveena HS treatment, aiming for device placement no later than 3 days into the anticipated HMB component of their menstrual cycle. Subjects will be provided access to and instructions for populating a diary based on the Mansfield-Voda-Jorgensen (MVJ) menstrual bleeding scale, to be started on day 1 of the index menstrual period. On treatment day, eligibility will be confirmed (including confirmation of HMB and a negative urine pregnancy test) and an MVJ score documented pre- and post-treatment. Phone visits will be conducted post-treatment Days 1, 14 and 56. Clinic visits will be conducted post-treatment on Day 7 and Day 28.