Clinical trial · Interventional
Clinical Test of the MRgHIFU System on Uterine Fibroids
For Research Purpose the Clinical Test of the Magnetic Resonance Imaging Guided Focused Ultrasound Ablation System on Uterine Fibroids
NCT02283502CI-TRIAL-00015994MRgHIFUunknownPhase 1ClinicalTrials.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 objectives of this program are to verify the safety and effectiveness of the MRgHIFU system developed by the division of Medical Engineering of National Health Research Institutes (NHRI)
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 |
|---|---|---|---|
| MRgHIFU system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention: MRgHIFU, Surgery
- description
- Magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system for the noninvasive treatment of uterine fibroids
- interventionNames
- Device: MRgHIFU system
Primary outcomes (1)
- measure
- Check Adverse Event or Serious Adverse Event
- timeFrame
- six month
- description
- follow up
Secondary outcomes (2)
- measure
- Using MRI to confirm the volume of the fibromyoma.
- timeFrame
- Screen, after treatment 1Month, 3Month, 6Month
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion criteria: 1. Already sign in the Informed Consent Form。 2. The woman who want to operate the Hysteromyomectomy, and the volume of the fibromyoma is between 5-10 cm, will be included。 3. Woman age between 35\~45 years, and do not want to be pregnant 4. Abdominal circumference≦95 ㎝. 5. No pregnant. 6. MRI compatible. Exclusion criteria: 1. Pregnant or Breast-feeding. 2. MRI uncompatible. 3. Woman who has scar in Abdomen. 4. Immunodeficiency or cancer. 5. Use the clinical medicine before 3 month age. 6. The woman who will not follow the project. -
References
Publications (0)
Data not yet available
No reference posted for this study.