Uterine Fibroid Clinical Trial
— PEDD-UFEOfficial title:
Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System (PEDD-UFE)
The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | June 30, 2025 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | TriSalus Life Sciences, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ovarian perfusion | Ultrasound doppler imaging will be used to assess changes in ovarian perfusion post-intervention compared to baseline ultrasound imaging | 6 months |
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