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Procedure

TriNaV for Uterine Fibroids (PEDD-UFE Trial)

N/A
Recruiting
Led By Dania Daye, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female, aged >18 years
Having either bulk symptoms or menorrhagia
Must not have
Diagnosis of endometriosis
Diagnosed gynecologic malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new way of delivering drugs to treat fibroids in women undergoing UFE.

Who is the study for?
This trial is for women over 18 with uterine fibroids who have decided to undergo Uterine Fibroid Embolization (UFE). They should have symptoms like heavy bleeding or a feeling of fullness and must not be pregnant, post-menopausal, or have had certain hormone treatments recently. Women with gynecologic cancer, pelvic inflammatory disease, or allergies to specific pain medications cannot participate.
What is being tested?
The study tests the effectiveness of TriNaV in improving drug delivery during UFE procedures aimed at treating fibroids. It evaluates if this method can better reduce pain and enhance blood flow to the ovaries after treatment compared to standard approaches.
What are the potential side effects?
Potential side effects may include discomfort from the procedure itself, reactions related to contrast materials used in MRI scans, and typical risks associated with embolization such as cramping, nausea, fever, or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman over 18 years old.
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I experience heavy menstrual bleeding or symptoms due to large growths.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with endometriosis.
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I have been diagnosed with a cancer that started in my reproductive organs.
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I have had a procedure to treat fibroids in my uterus.
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I have had my ovaries surgically removed.
Select...
I have been diagnosed with pelvic inflammatory disease.
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I have not had a menstrual period for over 12 months.
Select...
I have been diagnosed with adenomyosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain Reduction
Secondary study objectives
ovarian perfusion

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intervention ArmExperimental Treatment1 Intervention
Patient will undergo UFE using PEDD

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,015 Previous Clinical Trials
13,309,340 Total Patients Enrolled
TriSalus Life Sciences, Inc.Industry Sponsor
4 Previous Clinical Trials
252 Total Patients Enrolled
Dania Daye, MDPrincipal InvestigatorMassachusetts General Hospital
~1 spots leftby Dec 2024
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