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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Rejoni Inc.
Study ID
NCT06634719
Status
Recruiting
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Conditions

  • Heavy Menstrual Bleeding

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Oct 10, 2024
Start date
Feb 1, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
7 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Juveena Hydrogel System
    One time instillation of the Juveena Hydrogel into the uterine cavity.

Primary Outcome Measure

Primary Effectiveness Endpoint [ Time Frame: Within 7 days post-treatment ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Arizona Gynecology ConsultantsPhoenixArizona85006-
Applied Research Center of ArkansasLittle RockArkansas72205
Olivia McIver
[email protected]
870-917-8300
Nathan Livers, MD (PRINCIPAL_INVESTIGATOR)
Rubino OB/GYN (Axia Women's Health)West OrangeNew Jersey07052
Joanne Serra
[email protected]
973-736-1100
Robert Rubino, MD (PRINCIPAL_INVESTIGATOR)
Seven Hills Clinical Research Group, LLCCincinnatiOhio45255-

Find similar trials in Phoenix, AZ

By research site
Arizona Gynecology Consultants· Phoenix, AZApplied Research Center of Arkansas· Little Rock, ARRubino OB/GYN (Axia Women's Health)· West Orange, NJSeven Hills Clinical Research Group, LLC· Cincinnati, OH

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