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

NCT06634719 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-04-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Rejoni Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06634719 on ClinicalTrials.gov