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

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

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

Study Overview

• Status: Terminated
• Conditions: Uterine Fibroid; Uterine Bleeding
• Intervention / Treatment: Device: TriNaV

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Patient will undergo UFE using PEDD	Device: TriNaV; Assess Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Reduction	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ovarian perfusion	Ultrasound doppler imaging will be used to assess changes in ovarian perfusion post-intervention compared to baseline ultrasound imaging	6 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: TriSalus Life Sciences, Inc.
• Investigators: Principal Investigator: Dania Daye, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2023
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 20, 2025

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Connective Tissue Diseases; Neoplasms by Histologic Type; Uterine Diseases; Genital Diseases, Female; Hemorrhage; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Uterine Hemorrhage; Leiomyoma; Myofibroma
• Other Study ID Numbers: 2023P002406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes