Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization
Purpose
The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE.
Conditions
- Uterine Bleeding
- Uterine Fibroid
Eligibility
- Eligible Ages
- Between 18 Years and 60 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention Arm |
Patient will undergo UFE using PEDD |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
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.