Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-09

Study Completion Date

2025-01-20

Brief Summary

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

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Detailed Description

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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.

Conditions

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Uterine Bleeding Uterine Fibroid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Arm

Patient will undergo UFE using PEDD

Group Type EXPERIMENTAL

TriNaV

Intervention Type DEVICE

Assess Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System

Interventions

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TriNaV

Assess Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes