Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization

Uterine Fibroid Clinical Trial

— PEDD-UFE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106633
• Other study ID #: 2023P002406
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Massachusetts General Hospital
• Contact: Dania Daye, MD
• Phone: 617-726-8488
• Email: ddaye[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Bleeding
• Uterine Fibroid
• Uterine Hemorrhage

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	TriSalus Life Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ovarian perfusion	Ultrasound doppler imaging will be used to assess changes in ovarian perfusion post-intervention compared to baseline ultrasound imaging	6 months