Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization (PEDD-UFE)

Mass General Brigham

Status

Terminated

Conditions

Uterine Bleeding

Uterine Fibroid

Treatments

Device: TriNaV

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06106633

2023P002406

Details and patient eligibility

About

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

Full 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.

Enrollment

3 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.