Clinical trial · Interventional
China Clinical Trial for Therapeutic MR-HIFU Ablation of Uterine Fibroids
China Clinical Trial for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
NCT01588899CI-TRIAL-00019559completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to demonstrate safety and effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) for treatment of uterine fibroids in a Chinese population.
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 Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR-HIFU uterine fibroid treatment | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MR-HIFU Treatment
- description
- Patients in this arm will receive MR-HIFU uterine fibroid treatment
- interventionNames
- Device: MR-HIFU uterine fibroid treatment
Primary outcomes (2)
- measure
- Change in fibroid volume
- timeFrame
- At baseline and at 6 months after treatment
- description
- Proportion of patients with treated fibroid volume at 6 months after treatment reduced to 90% or less of treated fibroid volume at baseline (before MR-HIFU treatment)
- measure
- Adverse Events
- timeFrame
- Within 6 months after treatment
- description
- Number of Adverse Events reported as resulting from MR-HIFU treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Women, age between 18 and 55 years * Weight \< 140 kg * Pre- or peri-menopausal * Uterine size \< 24 weeks * Cervical cell assessment by Pap smear/Thin-prep Cytologic Test (TCT): Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue * Fibroids selected for treatment meeting the following criteria: 1. Total planned ablation volume of all fibroids should not exceed 250 ml, and 2. No more than 5 fibroids should be planned for ablation, and 3. Dominant fibroid (diameter) is greater than or equal to 3 cm, and 4. Fibroids which are completely non-enhancing under Magnetic Resonance (MR) contrast agent should not be treated as the identification of treated volume becomes ambiguous 5. Highly perfused or brighter than myometrium in T2-weighted MRI (according to the T2 contrast obtained using the Philips MR-HIFU protocol) fibroids should not be treated * MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid volume can be treated * Willing and able to attend all study visits Exclusion Criteria: * Other pelvic disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis) * Desire for future pregnancy * Significant systemic disease, even if controlled * Positive pregnancy test * Hematocrit \< 25% * Extensive scarring along anterior lower abdominal wall (\> 50% of area) * Surgical clips in the direct path of the HIFU beam * MRI contraindicated * MRI contrast agent contraindicated * Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements are not feasible) * Calcifications around or throughout uterine tissues * Communication barrier * Suspected malignancy
References
Publications (1)
- DERIVEDChen R, Keserci B, Bi H, Han X, Wang X, Bai W, Wang Y, Yang X, Yang J, Wei J, Seppala M, Viitala A, Liao Q. The safety and effectiveness of volumetric magnetic resonance-guided high-intensity focused ultrasound treatment of symptomatic uterine fibroids: early clinical experience in China. J Ther Ultrasound. 2016 Nov 3;4:27. doi: 10.1186/s40349-016-0072-9. eCollection 2016. PMID 27822376