An interventional study of Microwave ablation combined with chemical ablation and Microwave ablation in Uterine Fibroids (UF), Microwave Ablation and Ultrasound, sponsored by Peking University Aerospace Center Hospital. Not yet recruiting at 1 site in China. Open to female participants. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Peking University Aerospace Center Hospital · Not applicable, Interventional, and Treatment
Uterine fibroids are the most common benign tumors in women of reproductive age, with a prevalence of 20%-50%, often causing menorrhagia, anemia, pelvic pain, and pressure symptoms that markedly impair quality of life. Current treatments include pharmacological therapy (GnRH-a, mifepristone) - effective temporarily but with high recurrence after discontinuation; surgical myomectomy or hysterectomy - definitive yet invasive, with prolonged recovery and potential fertility compromise; and minimally invasive therapies such as uterine artery embolization (UAE), high-intensity focused ultrasound (HIFU), and microwave ablation (MWA), which are increasingly favored for their minimal invasiveness and rapid recovery.
MWA delivers thermal energy via a percutaneously inserted antenna under ultrasound guidance, inducing coagulative necrosis of fibroid tissue through temperatures exceeding 60°C. Advantages include minimal trauma (\~2 mm puncture), rapid recovery (discharge within 1-2 days), uterine preservation, and negligible ovarian impact. However, a key limitation is the heat sink effect: in hypervascular fibroids, flowing blood dissipates thermal energy, resulting in incomplete ablation, prolonged procedural time, and higher energy requirements - particularly challenging for fibroids >5 cm in diameter.
Chemical ablation involves intralesional injection of a sclerosing agent (e.g., lauromacrogol), which damages vascular endothelial cells, causing vascular occlusion, thrombosis, ischemic necrosis, and direct membrane disruption that accelerates apoptosis. Theoretically, pre-ablation chemical sclerotherapy may occlude feeding vessels, attenuate the heat sink effect, and enhance subsequent thermal ablation efficiency. Supporting this concept, an ex vivo bovine liver study demonstrated that pre-injection of 5 mL of 99.5% ethanol around the electrode prior to radiofrequency ablation produced a significantly larger ablation zone at equivalent energy levels compared with ablation alone. Small-sample clinical studies, including a prospective cohort from Shanghai Tenth People's Hospital, have preliminarily explored combined chemical ablation plus MWA for uterine fibroids, suggesting improved ablation rates and shorter procedural times, though findings require validation through high-quality randomized controlled trials.
Therefore, the investigators conducted this multicenter, prospective, randomized controlled trial to rigorously compare the safety (incidence and severity of adverse events) and efficacy (fibroid volume reduction rate, symptom improvement, quality-of-life outcomes) of MWA alone versus MWA combined with chemical ablation. This study aims to clarify the clinical value of the combined approach and provide high-quality, evidence-based data to guide the optimal selection of minimally invasive treatment strategies for uterine fibroids.
438 studies on the registry are indexed under Leiomyoma; 74 are open to participants now.
This study's planned enrollment of 248 is above the median of 66 across 306 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →Peking University Aerospace Center Hospital is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Microwave ablation of uterine fibroids was performed under real-time ultrasound guidance.
Procedure: Microwave ablation
Under real-time ultrasound guidance, chemical ablation of the uterine fibroid was performed first, followed by microwave ablation.
Procedure: Microwave ablation combined with chemical ablation
Microwave ablation combined with lauromacrogol of Uterine Fibroids
Microwave ablation of Uterine Fibroids
ablation rate of uterine fibroids
Time frame: 4 to 6 hours after the operation
Volume reduction rate
Time frame: 12 months after the operation
Complications
Time frame: 12 months after the operation
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Peking University Aerospace Center Hospital