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

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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