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

NCT06634719 | Recruiting DMC FDA Device

• 1 other identifier: REJ-CT-0008
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 4

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.

Conditions

Heavy Menstrual Bleeding

Outcome Measures

Primary Outcomes (1)

• Primary Effectiveness Endpoint

  Feasibility for invoking a tamponade effect

  Within 7 days post-treatment

Other Outcomes (1)

• Bleeding Control

  Within 7 days post-treatment

Study Arms (1)

Juveena Hydrogel System

EXPERIMENTAL

One time instillation of the Juveena Hydrogel into the uterine cavity.

Device: Juveena Hydrogel System

Interventions

Juveena Hydrogel System DEVICE

The 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.

Juveena Hydrogel System

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women with history of chronic HMB
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Menses regularity - shortest to longest period is ≤8 days based on subjectparticipant reporting.
• 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).
• HMB refractory to hormone therapy, hormone therapy contraindicated, or subjectparticipant does not wish to continue hormone therapy.
• The subjectparticipant is literate and clearly demonstrates an understanding of how to complete the MVJ Scale and other patient-reported outcomes.
• Able and willing to comply with the study protocol and agrees to the following during participation in the study:
• Use an effective non-hormonal method of birth control until the Day 28 visit. Acceptable methods of birth control for use in this study are abstinence and barrier contraceptives (e.g. condom)
• No initiation or continuation of hormone use (including contraception) or any other medical intervention for bleeding until after the Day 28 visit (unless clinically necessary, e.g., the subjectparticipant becomes hemodynamically unstable)
• Attends the follow-up examexams and completion of electronic diaries via a secured internet website (subject must have internet accesscompletes the MVJ scale and will be trained on how to use the eDiary)other patient-reported outcomes per the schedule of events
• Demonstrates understanding of the study and signs the written informed consent form.

You may not qualify if:

• 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.
• Suspected or known malignancy or premalignant condition of the uterus including the cervix
• Active pelvic infection.
• Active sexually transmitted disease (STD) at the time of treatment (STD testing to be performed)
• Presence of bacteremia, sepsis, or other active systemic infection
• Currently on anticoagulants
• History of allergies to PEG or FD\&C Blue#1 dye
• Planning to undergo surgery or other treatments for HMB during the study period (i.e., 8 weeks post-hydrogel instillation).
• AUB-L sm with a Type 0 or 1 leiomyoma \> 1 cm
• AUB-P (Polyp) \> 2 cm in maximum dimension based on ultrasound, hysteroscopy, or MRI performed within prior 6 months.
• AUB-O, Irregular menstrual cycles (cycle length variability \>7 days length)
• AUB-C (coagulopathy or bleeding disorder)

Sponsors & Collaborators

• Rejoni Inc.: lead

Study Sites (4)

Arizona Gynecology Consultants

Phoenix, Arizona, 85006, United States

WITHDRAWN

Applied Research Center of Arkansas

Little Rock, Arkansas, 72205, United States

RECRUITING

Rubino OB/GYN (Axia Women's Health)

West Orange, New Jersey, 07052, United States

RECRUITING

Seven Hills Clinical Research Group, LLC

Cincinnati, Ohio, 45255, United States

COMPLETED

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Central Study Contacts

Ian Feldberg

CONTACT

1-978-760-1742; ian.feldberg@rejoni.com

Jonathan Bissett

CONTACT

1-617-877-7599; jonathan.bissett@rejoni.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Women with HMB

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 10, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)