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RecruitingNot ApplicableNCT06634719

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)

Sponsor

Rejoni Inc.

Enrollment

7 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Heavy Menstrual Bleeding

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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Juveena Hydrogel System for people with heavy menstrual bleeding. The study is currently recruiting participants at 4 locations. People eligible for this study include women aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEJuveena 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

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NCT06634719

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