NCT06634719

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

A Prospective Multicenter Safety and Feasibility Study of the Juveena Hydrogel System for Use for Temporary Control of Chronic Ovulatory Heavy Menstrual Bleeding (HMB)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (estimated)
• Sponsor: Rejoni Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Heavy Menstrual Bleeding

Interventions

Type	Name	Description
DEVICE	Juveena Hydrogel System	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.

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-10-10
• Last updated: 2025-11-20

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study