Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization

Last updated: April 20, 2025
Sponsor: Massachusetts General Hospital
Overall Status: Terminated

Phase

N/A

Condition

Uterine Disorders

Uterine Fibroids

Desmoid Tumors

Treatment

TriNaV

Clinical Study ID

NCT06106633
2023P002406
  • Ages 18-60
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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

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 priorto entering the study.

  12. Target uterine vasculature not suitable for treatment with the TriNav InfusionSystem.

  13. Allergy or intolerance to dilaudid.

  14. Lack of ovarian perfusion on baseline MRI.

Study Design

Total Participants: 3
Treatment Group(s): 1
Primary Treatment: TriNaV
Phase:
Study Start date:
February 09, 2023
Estimated Completion Date:
January 20, 2025

Study 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.

Connect with a study center

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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