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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06106633
• Collaborator: TriSalus Life Sciences, Inc. (Industry)
• Enrollment: 20
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 19.9
• Patients Per Site: 10
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Uterine Bleeding; Uterine Fibroid	Device: TriNaV	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System (PEDD-UFE)
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Dec 30, 2024
• Anticipated Study Completion Date: Jun 30, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. ovarian perfusion [6 months]

   Ultrasound doppler imaging will be used to assess changes in ovarian perfusion post-intervention compared to baseline ultrasound imaging

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Massachusetts General Hospital
• TriSalus Life Sciences, Inc.

Investigators

• Principal Investigator: Dania Daye, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dania Daye, MD, PhD, Assistant Professor of Radiology, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT06106633
• Other Study ID Numbers: 2023P002406
• First Posted: Oct 30, 2023
• Last Update Posted: Oct 31, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Leiomyoma; Myofibroma; Uterine Hemorrhage

Study Results

No Results Posted as of Oct 31, 2023