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RECRUITING
NCT06634719
NA

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

Sponsor: Rejoni Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

7

Start Date

2025-02-01

Completion Date

2025-12-31

Last Updated

2025-11-20

Healthy Volunteers

No

Interventions

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.

Locations (4)

Arizona Gynecology Consultants

Phoenix, Arizona, United States

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

Rubino OB/GYN (Axia Women's Health)

West Orange, New Jersey, United States

Seven Hills Clinical Research Group, LLC

Cincinnati, Ohio, United States