Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization

Massachusetts General Hospital3 enrolled

Overview

The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE.

Uterine fibroids are the most common tumor type in women of reproductive age and may be associated with abnormal menstrual bleeding, pain, sub-fertility, and diminished quality of life. For women interested in uterine preservation who want to derive adequate relief from medical management, uterine fibroid embolization (UFE) is a treatment option. The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Uterine Bleeding Uterine Fibroid

Interventions

TriNaVDEVICE

Assess Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female, aged \>18 years. 2. Prior clinical decision for treatment by UFE. 3. One or more enhancing intramural, submucosal or subserosal fibroids on MRI. 4. Having either bulk symptoms or menorrhagia. Exclusion Criteria: 1. Absolute contraindication to contrast-enhanced MRI. 2. Current pregnancy. 3. Known history of adenomyosis. 4. Diagnosis of pelvic inflammatory disease. 5. Diagnosis of endometriosis. 6. Post-menopausal (no menses \>12-months). 7. Diagnosed gynecologic malignancy. 8. Prior uterine fibroid embolization treatment. 9. \>50% volume of non-enhancing fibroids. 10. Prior oophorectomy 11. GnRH agonist therapy within 6-months or GnRH antagonist therapy within 1-month prior to entering the study. 12. Target uterine vasculature not suitable for treatment with the TriNav Infusion System. 13. Allergy or intolerance to dilaudid. 14. Lack of ovarian perfusion on baseline MRI.

Locations (2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Pain Reduction

The Visual Analog Scale (VAS) Pain score will be used to assess pre- and post-procedural pain. The scale is from 1 to 10 with 1 indicating no pain and 10 indicating extreme pain.

Time frame: 6 months

Secondary Outcomes

ovarian perfusion

Ultrasound doppler imaging will be used to assess changes in ovarian perfusion post-intervention compared to baseline ultrasound imaging

Time frame: 6 months

Data from ClinicalTrials.gov

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