Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization

Not Applicable

Terminated

• Conditions: Uterine Bleeding; Uterine Fibroid
• Interventions: Device: TriNaV

• Registration Number: NCT06106633
• Lead Sponsor: Massachusetts General Hospital

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 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.

Study Timeline

• Study Start: 2023-02-09
• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-10-30
• Primary Completion: 2025-01-15
• Study Completion: 2025-01-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-20
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Arm	TriNaV	Patient will undergo UFE using PEDD

Primary Outcome Measures

Name	Time	Method
Pain Reduction	6 months	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.

Secondary Outcome Measures

Name	Time	Method
ovarian perfusion	6 months	Ultrasound doppler imaging will be used to assess changes in ovarian perfusion post-intervention compared to baseline ultrasound imaging

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States