Status:
TERMINATED
Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
TriSalus Life Sciences, Inc.
Conditions:
Uterine Bleeding
Uterine Fibroid
Eligibility:
FEMALE
18-60 years
Phase:
NA
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 inte...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2025
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT06106633
Start Date
February 9 2023
End Date
January 20 2025
Last Update
April 24 2025
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115