Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB)
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Female aged 18 to 45 years inclusive seeking treatment for HMB 2. Recent history (within the last 3 months) of repeat periods of HMB that adversely affects quality of life (Modified SAMANTA score ≥4 and comprises at least three consecutive days of HMB, see Appendix 2).(23). 3. Historical menstrual pattern with at least 3 days (72 hours) of HMB as determined by retrospective MVJ Bleeding scale score of ≥5for prior cycle. 4. Menses frequency (24-38 days) based on subjectparticipant reporting. 5. Menses regularity - shortest to longest period is ≤8 days based on subjectparticipant reporting. 6. Actively experiencing heavy to very heavy menstrual bleeding (HMB) at the time of the Juveena HS treatment, i.e., MVJ score of ≥5 (treatment must be performed no later than Day 3 of the index period). 7. HMB refractory to hormone therapy, hormone therapy contraindicated, or subjectparticipant does not wish to continue hormone therapy. 8. The subjectparticipant is literate and