Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06106633
Other study ID # 2023P002406
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Terminated NCT04073485 - Microwave Ablation for Uterine Fibroids N/A
Recruiting NCT04519593 - ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma N/A
Recruiting NCT01239641 - High Intensity Focused Ultrasound Ablation Virus Myomectomy to Treat Uterine Fibroids Phase 4
Recruiting NCT04748978 - OPPIuM Technique and Myolysis With Diode Laser Dwls N/A
Not yet recruiting NCT04191603 - TWO DÄ°FFERENT ELECTROSURGERY DEVICES AS MONOPOLAR HOOC AND PLASMAKINETIC BIPOLAR SPATULA EFFECTIVENESS DURING COLPOTOMY N/A
Terminated NCT04132349 - Ulipristal Acetate in Symptomatic Uterine Fibroid Phase 4
Completed NCT03412890 - LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Completed NCT03021720 - Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial N/A
Recruiting NCT04209036 - Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training?
Completed NCT05086770 - Comparison of Pain After Uterine Artery Embolization Using Gelatin Microsphere or Tris-acryl Gelatin Microsphere N/A
Recruiting NCT05416424 - Life Study: Lifestyle Intervention in Fibroid Elimination N/A
Not yet recruiting NCT05695690 - Role of US in Uterine Fibroids in Comparison With MRI Using FIGO Classification
Enrolling by invitation NCT06430320 - Ascertaining Longterm Outcomes of Fibroid Treatments
Completed NCT04832906 - UA Versus UAE in Treatment of Fibroids Phase 4
Completed NCT03444987 - The Role of Fibroblast Activation in Uterine Fibroid
Active, not recruiting NCT06244251 - Comparison Between Laparoendoscopic Single-site Surgery and Multi-port Laparoscopy in Treating Uterine Fibroids N/A
Not yet recruiting NCT06153667 - Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)
Not yet recruiting NCT03450421 - Safety and Efficacy of Actamaxâ„¢Adhesion Barrier in Women Undergoing Laparoscopic Abdominopelvic Surgery/Myomectomy N/A
Not yet recruiting NCT05840042 - Epidemiology and Risk Factors of Uterine Fibroids in China
Completed NCT04345003 - MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids N/A