Frontlight ResearchEarly access
TerminatedNo phase
Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization
Key facts
- Who runs it
- Massachusetts General Hospital
- Where
- Boston, United StatesSee the 2 sites
- Trial code
- Status
- Terminated
- People taking part
- 3 people enrolled
- Started
- 9 Feb 2023
- Ended
- 20 Jan 2025
- Type of study
- Interventional
- Treatments tested
- TriNaV
- Record updated
- 24 April 2025
- Why it stopped
- Insufficient Enrollment
Who can take part
- Age
- 18 years to 60 years
- Sex
- Women only
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- Female, aged >18 years
- Prior clinical decision for treatment by UFE
- One or more enhancing intramural, submucosal or subserosal fibroids on MRI
- Having either bulk symptoms or menorrhagia
Who cannot take part
- Prior uterine fibroid embolization treatment
- Prior oophorectomy
- GnRH agonist therapy within 6-months or GnRH antagonist therapy within 1-month prior to entering the study
- Target uterine vasculature not suitable for treatment with the TriNav Infusion System
- Known history of adenomyosis
- Diagnosis of pelvic inflammatory disease
- Diagnosed gynecologic malignancy
- Allergy or intolerance to dilaudid
- Absolute contraindication to contrast-enhanced MRI
- Current pregnancy
- Diagnosis of endometriosis
- Post-menopausal (no menses >12-months)
- >50% volume of non-enhancing fibroids
- Lack of ovarian perfusion on baseline MRI
Where in United States
- Brigham and Women's HospitalBoston, United States
- Massachusetts General HospitalBoston, United States
About the trial
What the trial wants to find out
The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE.
The group in the trial
- Intervention ArmTreatment being tested
Patient will undergo UFE using PEDD
Treatment: TriNaV
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System (PEDD-UFE)
- Record updated
- 24 April 2025