Clinical trial · Interventional
Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization
Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System (PEDD-UFE)
NCT06106633CI-TRIAL-00088864PEDD-UFEterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient Enrollment
Summary
Brief summary (as posted)
The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Bleeding | — | UNRESOLVED | — |
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TriNaV | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention Arm
- description
- Patient will undergo UFE using PEDD
- interventionNames
- Device: TriNaV
Primary outcomes (1)
- measure
- Pain Reduction
- timeFrame
- 6 months
- description
- 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.
Secondary outcomes (1)
- measure
- ovarian perfusion
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.