Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization

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

Detailed Description
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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.

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

Conditions
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Uterine Bleeding, Uterine Fibroid

Intervention / Treatment
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* Device: TriNaV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Absolute contraindication to contrast-enhanced MRI. Current pregnancy. Known history of adenomyosis. Diagnosis of pelvic inflammatory disease. Diagnosis of endometriosis. Post-menopausal (no menses >12-months). Diagnosed gynecologic malignancy. Prior uterine fibroid embolization treatment. >50% volume of non-enhancing fibroids. Prior oophorectomy GnRH agonist therapy within 6-months or GnRH antagonist therapy within 1-month prior to entering the study. Target uterine vasculature not suitable for treatment with the TriNav Infusion System. Allergy or intolerance to dilaudid. Lack of ovarian perfusion on baseline MRI.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>Patient will undergo UFE using PEDD | Device: TriNaV<br>* Assess Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ovarian perfusion | Ultrasound doppler imaging will be used to assess changes in ovarian perfusion post-intervention compared to baseline ultrasound imaging | 6 months |