Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB)
ConditionHeavy Menstrual Bleeding
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorRejoni Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
Female aged 18 to 45 years inclusive seeking treatment for HMB
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).
Historical menstrual pattern with at least 3 days (72 hours) of HMB as determined by retrospective MVJ Bleeding scale score of ≥5for prior cycle.
Menses frequency (24-38 days) based on subjectparticipant reporting.
Disqualifiers
Pregnancy and/or breastfeeding within the past 3 months or planning to become pregnant during the duration of this study.
Currently using an intrauterine device (IUD) or has undergone removal within the last 2 menstrual cycles.
Dysmenorrhea of a severity that, in the opinion of the investigator, precludes participation in the study.
Hemoglobin of < 8 g/dL at the time of screening.
Trial design
Design model
Single group
Treatments tested in this trial
Juveena Hydrogel System
DeviceThe Juveena Hydrogel System is a single-use device that is instilled into the endometrial cavity as a liquid and sets up as a gel intrauterine tamponade within seconds.
Treatment groups
7 Participants
are divided into 1 treatment groupGroup A: Juveena Hydrogel SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Effectiveness Endpoint
Feasibility for invoking a tamponade effect
Time frame
Within 7 days post-treatmentOther outcomes
1
Bleeding Control
The proportion of subjects achieving bleeding control defined as none or spotting (MVJ ≤1)
Time frame
Within 7 days post-treatmentSponsors and contacts
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Source ClinicalTrials.gov