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Trial Title:
Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization
NCT ID:
NCT06106633
Condition:
Uterine Bleeding
Uterine Fibroid
Conditions: Official terms:
Leiomyoma
Myofibroma
Uterine Hemorrhage
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
TriNaV
Description:
Assess Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via
Pressure-Enabled Drug Delivery With the TriNav Infusion System
Arm group label:
Intervention Arm
Summary:
The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid
treatment in patients undergoing UFE.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dania Daye, MD
Phone:
617-726-8488
Email:
ddaye@mgh.harvard.edu
Investigator:
Last name:
Dania Daye, MD
Email:
Principal Investigator
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Maria Koch, MD
Phone:
617-732-7240
Email:
rmkoch@bwh.harvard.edu
Investigator:
Last name:
Maria Koch, MD
Email:
Principal Investigator
Start date:
February 9, 2023
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
TriSalus Life Sciences, Inc.
Agency class:
Industry
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06106633
