Clinical trial · Interventional
Therapeutic MRI-HIFU Ablation of Uterine Fibroids in a 3T MRI Scanner
Clinical Trial Protocol for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids in a 3T MRI Scanner
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to collect supplementary safety and technical effectiveness data of Philips MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic fibroids in a 3T MRI scanner. The importance of this therapy is that it offers a non-invasive, uterine sparing procedure for the treatment of uterine fibroids in pre- and peri- menopausal women. MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate fibroid tissue. The MRI system identifies the ultrasound path and monitors heat rise in the fibroid tissue. The goal of the study is to collect supplementary 3T treatment safety and technical effectiveness data in a 1 month follow-up study. MRguided HIFU will be performed in patients who pass inclusion/exclusion criteria. Safety, quality of life, and imaging endpoints will be evaluated in all study patients.
Conditions
Conditions (1)
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 Leiomyomas | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Philips MR-guided HIFU system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treated leiomyomas
- description
- Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure are treated with the Philips MR-guided HIFU system. Patients must have completed child bearing prior to enrolling in this study.
- interventionNames
- Device: Philips MR-guided HIFU system
Primary outcomes (2)
- measure
- Safety of HIFU for treatment of the uterine fibroids as determined by adverse event reporting.
- timeFrame
- 30 days after treatment
- description
- Number of adverse events reported in the study divided by the total number of treated subjects.
- measure
- Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 59 Years
Show eligibility criteria text
Inclusion Criteria: * Women, age between 18 and 59 years * Weight \< 140kg * Pre- or peri-menopausal * Uterine size \< 24 weeks * Transformed SSS score \> 40 * Normal Cervical cell assessment by PAP * Symptomatic Fibroid disease * Dominant fibroid greater than or equal to 3cm and less than or equal to 12 cm Exclusion Criteria: * Other Pelvic Disease * Desire for future pregnancy * Significant systemic disease even if controlled * Positive pregnancy test * Hematocrit \< 25% * Scarring or other interference of the HIFU beam * MRI or contrast contraindicated * Fibroids not quantifiable on MRI * Calcifications around or throughout uterine tissues * Communication barrier
References
Publications (1)
- BACKGROUNDSpies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002 Feb;99(2):290-300. doi: 10.1016/s0029-7844(01)01702-1. PMID 11814511