Clinical trial · Interventional
Microwave Ablation for Uterine Fibroids
NCT04073485CI-TRIAL-00066118terminatedN/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): poor patient accrual
Summary
Brief summary (as posted)
This study is aimed to evaluate the clinical safety and effectiveness of Microwave ablation (MWA) in treating patients with uterine fibroid.
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 Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microwave ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Microwave ablation
- description
- The uterine fibroid will be identified and located with ultrasonography. A microwave electrode appropriate for the size of target lesion is placed into the target lesion under ultrasound guidance. Appropriate microwave power and application time are selected to provide sufficient ablation coverage to the target lesion.
- interventionNames
- Procedure: Microwave ablation
Primary outcomes (1)
- measure
- Assessment of technical success
- timeFrame
- within one hour
- description
- Technical success was defined as successful completion of the planned treatment of target lesions
Secondary outcomes (2)
- measure
- Assessment of adverse effects and complications
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. Symptomatic fibroids with or without focal adenomyoma 2. Female gender 3. Age between 30 and 50 4. Pre or peri menopausal with FSH less than 40 mIU/ml 5. Negative urine pregnancy test 6. Uterine size less than 22 weeks based on physical exam assessment 7. Dominant intramural fibroid greater than or equal to 3 cm and less than or equal to 10 cm on imaging. 8. Good health other than history of leiomyomas. Chronic medications may be acceptable at the discretion of the research team. 9. Are using abstinence, mechanical (condoms, diaphragms) or sterilization methods of contraception and are willing to continue using them throughout the study. 10. Willing and able to give informed consent. 11. Willing and able to comply with study requirements. 12. Normal menstrual cycle with endometrial pathology excluded Exclusion Criteria: 1. History of or current thromboembolic event (deep vein thrombosis, pulmonary embolus, stroke) 2. Other pelvic pathology as indicated by history or MR imaging such as endometriosis, ovarian tumor, acute or chronic pelvic inflammatory disease 3. Pregnant or Positive pregnancy test 4. Unexplained vaginal bleeding 5. Untreated severe cervical dysplasia 6. Abnormal adnexal /ovarian mass 7. Intrauterine device 8. Known recent rapid growth of fibroids, defined as a doubling in size in 6 months 9. Known bleeding tendency 10. Contraindication to MRI due to severe claustrophobia or implanted metallic device.
References
Publications (0)
Data not yet available
No reference posted for this study.