Uterine BleedingPEDD-UFENCT06106633
Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization
A study testing TriNaV in people with Uterine Bleeding and Uterine Fibroid, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Bleeding, Uterine Fibroid
- What is being tested?
- TriNaV
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Feb 2023to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 join
- Absolute contraindication to contrast-enhanced MRI.
- Current pregnancy.
- Known history of adenomyosis.
- Diagnosis of pelvic inflammatory disease.
- Diagnosis of endometriosis.
- Post-menopausal (no menses >12-months).
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- Diagnosed gynecologic malignancy.
- Prior uterine fibroid embolization treatment.
- >50% volume of non-enhancing fibroids.
- 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.
- Allergy or intolerance to dilaudid.
- Lack of ovarian perfusion on baseline MRI.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System (PEDD-UFE)
The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE.
Read the 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.
- Conditions
- Uterine Bleeding, Uterine Fibroid
- Being tested
- TriNaV
- Medical subject headings
- Uterine Hemorrhage, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriNaVDevice
Assess Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Patient will undergo UFE using PEDD Receives: Device: TriNaV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
ovarian perfusion
Ultrasound doppler imaging will be used to assess changes in ovarian perfusion post-intervention compared to baseline ultrasound imaging
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start9 Feb 2023
- Primary completion15 Jan 2025
- Study completion20 Jan 2025
Why it stopped: Insufficient Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine BleedingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TriSalus Life Sciences, Inc.
- Responsible party
- Principal investigator, Dania Daye, MD, PhD, Massachusetts General Hospital
- Investigators
- Dania Daye, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106633
- Sponsor's protocol ID
- 2023P002406
- Acronym
- PEDD-UFE
- Status last verified
- Apr 2025
- First submitted
- 23 Oct 2023
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System (PEDD-UFE)
- ClinicalTrials.gov ID
- NCT06106633
- Acronym / sponsor ID
- PEDD-UFE / 2023P002406
- Conditions
- Uterine Bleeding, Uterine Fibroid
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient Enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- TriSalus Life Sciences, Inc.
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: TriNaVPatient will undergo UFE using PEDD |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- Absolute contraindication to contrast-enhanced MRI.
- Current pregnancy.
- Known history of adenomyosis.
- Diagnosis of pelvic inflammatory disease.
- Diagnosis of endometriosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriNaVAssess Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System | Device | Intervention Arm |
Primary outcome
Pain Reduction
Time frame: 6 months
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.
1 secondary outcome
ovarian perfusion
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Insufficient Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dania Daye, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TriNaV in people with Uterine Bleeding and Uterine Fibroid, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient Enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Reduction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.