Suspended

PEDD-UFEPain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System (PEDD-UFE)

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What is being tested

TriNaV

Device
Who is being recruted

Urogenital Diseases+12

+ Genital Diseases

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 60 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2023
See protocol details

Summary

Principal SponsorMassachusetts General Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 9, 2023

Actual date on which the first participant was enrolled.

Uterine fibroids are non-cancerous growths that frequently occur in women of childbearing age. They can cause symptoms such as heavy menstrual bleeding, pain, and sometimes affect fertility, impacting overall quality of life. This study aims to improve treatment for women who want to keep their uterus and find relief beyond what standard medical treatments provide. The focus is on using a technique called Pressure-Enabled Drug Delivery during a procedure known as uterine fibroid embolization (UFE). The study's goal is to see if this method can better manage fibroid symptoms and improve life quality for these women. Participants in this study undergo uterine fibroid embolization, a minimally invasive procedure where blood flow to the fibroids is blocked to shrink them. The study uses a specific drug delivery system, the TriNav Infusion System, to administer treatment directly to the fibroids. Researchers will evaluate how well this approach reduces pain and improves blood flow to the ovaries. The study seeks to determine the effectiveness and safety of this targeted treatment method, aiming to offer a better alternative for fibroid management.

Official TitlePain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System (PEDD-UFE)
NCT06106633
Principal SponsorMassachusetts General Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleHemorrhageLeiomyomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Muscle TissuePathologic ProcessesPathological Conditions, Signs and SymptomsUterine DiseasesUterine HemorrhageNeoplasms, Connective and Soft TissueFemale Urogenital Diseases

Criteria

4 inclusion criteria required to participate
Female, aged >18 years.

Prior clinical decision for treatment by UFE.

One or more enhancing intramural, submucosal or subserosal fibroids on MRI.

Having either bulk symptoms or menorrhagia.

14 exclusion criteria prevent from participating
Absolute contraindication to contrast-enhanced MRI.

Current pregnancy.

Known history of adenomyosis.

Diagnosis of pelvic inflammatory disease.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patient will undergo UFE using PEDD

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Massachusetts General Hospital

Boston, United StatesOpen Massachusetts General Hospital in Google Maps
Suspended

Brigham and Women's Hospital

Boston, United States
Suspended2 Study Centers