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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

PEDD-UFE Trial 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.Check my eligibility

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.See study design

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.

PEDD-UFE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman over 18 years old.

Select...

I experience heavy menstrual bleeding or symptoms due to large growths.

PEDD-UFE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain Reduction

Secondary outcome measures

ovarian perfusion

PEDD-UFE Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention ArmExperimental Treatment1 Intervention

Patient will undergo UFE using PEDD

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,935 Previous Clinical Trials

13,198,621 Total Patients Enrolled

TriSalus Life Sciences, Inc.Industry Sponsor

4 Previous Clinical Trials

252 Total Patients Enrolled

Dania Daye, MDPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are my particular medical characteristics compatible with participation in this research endeavor?

"The qualifications to join this medical investigation necessitate uterine bleeding and age between 18 and 60. This survey is seeking a total of 20 participants."

Answered by AI

Are elderly people being included in the research for this experiment?

"For this trial, participants must be within the age range of 18 to 60 years old. There are 3 studies available for those under 18 and 27 studies designed for people over 65."

Answered by AI

Is there an opportunity to sign up for this clinical trial?

"According to clinicaltrials.gov, this trial is no longer accepting candidates as it was last updated on October 27th 2023. While the study has completed its recruitment process, there are presently 60 other trials that are actively looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization

Dania Daye, MD, PhD 2023. "Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06106633.

All > Uterine Fibroids > Uterine Fibroid