Uterine Fibroids (UF)NCT07754877
Safety and Efficacy of Microwave Ablation Alone Versus Microwave Ablation Combined With Chemical Ablation in the Treatment of Uterine Fibroids: A Prospective, Multicenter Study
A study testing Microwave ablation combined with chemical ablation and Microwave ablation in people with Uterine Fibroids (UF) and Microwave Ablation, run by Peking University Aerospace Center Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Uterine Fibroids (UF), Microwave Ablation, Ultrasound
- What is being tested?
- Microwave ablation combined with chemical ablation and Microwave ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 30 Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A definitive diagnosis of uterine fibroids confirmed by magnetic resonance imaging (MRI) and ultrasonography, with the International Federation of Gynecology and Obstetrics (FIGO) classification 0-6;
- At least one of the following symptoms: menorrhagia, secondary anemia, abdominal/pelvic pain, or compression symptoms;
- Absence of perimenopausal signs;
- A safe transabdominal puncture route accessible under imaging guidance.
Who cannot join
- Suspicion of malignancy on ultrasound or MRI that cannot be ruled out (e.g., uterine sarcoma; uterine fibroids coexisting with cervical, endometrial, or ovarian cancer; or other gynecological malignancies);
- Uterine fibroids with coexisting adenomyosis;
- Menstrual, gestational, or lactational period;
- Uterine fibroids classified as FIGO type 7;
- Known allergy to alcohol, lauromacrogol, or related sclerosing agents;
- Absence of a safe percutaneous puncture route (e.g., lesion adherent to critical structures - bowel, bladder, or major vessels - that cannot be safely separated);
Show all 12Show fewer
- Uncontrolled acute pelvic inflammatory disease;
- Significant hepatic, renal, or other major organ dysfunction;
- Severe coagulopathy, defined as platelet count <50 × 10⁹/L, prothrombin time >25 s, or prothrombin activity <40%;
- History of other malignancies;
- Participation in another clinical trial within 1 month prior to informed consent;
- Any other condition deemed by the investigator to render the subject unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Aerospace center hospital
Beijing
Lei Liang, 010-59971599, lianglei_csk@126.com
About this study
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.
Read more
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.
- Conditions
- Uterine Fibroids (UF), Microwave Ablation, Ultrasound
- Being tested
- Microwave ablation combined with chemical ablation, Microwave ablation
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave ablation combined with chemical ablationProcedure or surgery
Microwave ablation combined with lauromacrogol of Uterine Fibroids
Microwave ablationProcedure or surgery
Microwave ablation of Uterine Fibroids
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | Microwave ablation of uterine fibroids was performed under real-time ultrasound guidance. Receives: Procedure: Microwave ablation |
| Experimental group | Experimental | Under real-time ultrasound guidance, chemical ablation of the uterine fibroid was performed first, followed by microwave ablation. Receives: Procedure: Microwave ablation combined with chemical ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ablation rate of uterine fibroids
Measured: 4 to 6 hours after the operation
Secondary outcomes (2)
Volume reduction rate
Measured: 12 months after the operation
Complications
Measured: 12 months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Fibroids (UF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- microwave ablation lauromacrogol
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Aerospace Center Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Lei, Peking University Aerospace Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754877
- Sponsor's protocol ID
- 2026（115）
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No