Non-invasive treatment for benign uterine tumors using focused ultrasound
Official title: Fellow Docotor, Master's Degree
Run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · NCT06435663 · Data updated 2026-11-12
This study is testing a new non-invasive treatment using focused ultrasound to see if it can safely shrink benign uterine tumors in women with fibroids or adenomyosis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine Academic / other |
| Locations | 1 site (Yiwu, Zhejiang) |
| Status | Recruiting |
| Started | December 1, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | February 17, 2025 |
| Trial ID | NCT06435663 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult women diagnosed with uterine fibroids or adenomyosis who meet specific imaging and health criteria.
✕Probably not a fit
Patients with rapidly growing fibroids, unclear diagnoses, or significant health issues may not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of high-intensity focused ultrasound ablation (HIFUA) as a non-invasive treatment for patients with uterine fibroids and adenomyosis. The approach utilizes MRI guidance to accurately target and destroy fibroid tissue while preserving surrounding healthy tissue. Patients will be evaluated based on specific imaging criteria and overall health to determine their eligibility for the treatment. The trial aims to assess the efficacy and safety of this innovative technique in a clinical setting.
Why it matters
Potential benefit: If successful, this treatment could provide a safer, non-invasive option for women suffering from uterine fibroids and adenomyosis.
How similar studies have gone: Previous studies have shown the safety and effectiveness of MRI-guided HIFUA for treating uterine fibroids, indicating a promising approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:Patients with clinically diagnosed uterine fibroids or adenomyosis who meet the following conditions: 1) Imaging shows that the uterine fibroids are located between the muscle walls, or are pedunculated subserosal or submucosal fibroids, which are classified as types 2-6 by the International Federation of Gynecology and Obstetrics (FIGO); The diagnosis of adenomyosis is clear; 2) The imaging shows that there is no intestinal obstruction between uterine fibroids or adenomyosis and the abdominal wall, or the impact of intestinal obstruction can be eliminated through treatment, making it a safe treatment path; 3) Abdominal subcutaneous fat thickness ≤ 4 cm; 4) The farthest distance from the abdominal wall skin to the target area for treating fibroids is ≤ 14 cm; 5) The patient is generally in good condition and can tolerate and maintain a prone position for 2 hours or longer. 6) Adult and infertile women.Exclusion criteria:1) Unclear clinical diagnosis; 2) Uterine fibroids or adenomyosis rapidly increase in the short term, or imaging suggests a tendency for malignancy, or the malignant potential is uncertain; 3) Acute skin infection in the treatment area; 4) Uncontrolled acute pelvic inflammatory disease; 5) The general condition is poor, with severe dysfunction of important organs such as the heart, liver, and kidneys; 6) Severe coagulation dysfunction; 7) There are large skin scars in the treatment area of the lower abdomen. 8) Sedative and analgesic drugs cannot be used; 9) Postmenopausal enlarged uterine fibroids or adenomyosis. 10) Pregnant women, individuals with mental disorders, cognitive impairments, etc. who are unable to cooperate with treatment.
Where it's running
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The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Yu Zhang
- Email: jigoulunli_zy4y@163.com
- Phone: +86 0579-89935052
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.