NCT06106633

Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Uterine Bleeding
• Uterine Fibroid

Interventions

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

Timeline

• Start date: 2023-02-09
• Primary completion: 2025-01-15
• Completion: 2025-01-20
• First posted: 2023-10-30
• Last updated: 2025-04-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study