Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System (PEDD-UFE)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- Pain Reduction
Study Overview
Brief Summary
The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Intervention Arm
Patient will undergo UFE using PEDD
Intervention: TriNaV (Device)
Outcomes
Primary Outcomes
Pain Reduction
Time Frame: 6 months
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.
Secondary Outcomes
- ovarian perfusion(6 months)
Investigators
Dania Daye, MD, PhD
Assistant Professor of Radiology
Massachusetts General Hospital