PEDD-UFEPain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System (PEDD-UFE)
TriNaV
Urogenital Diseases+12
+ Genital Diseases
+ Female Urogenital Diseases and Pregnancy Complications
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.3 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
Massachusetts General Hospital
Boston, United StatesOpen Massachusetts General Hospital in Google MapsBrigham and Women's Hospital
Boston, United States