Clinical trial Recruiting at 1 site Interventional Ages 18 to 50 Women only

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 typeInterventional
Ages18 Years to 50 Years
SexWomen only
Enrollment30 (estimated)
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine
Academic / other
Locations1 site (Yiwu, Zhejiang)
StatusRecruiting
StartedDecember 1, 2024
Main results expectedDecember 31, 2025
Study endsDecember 31, 2025
Registry record updatedFebruary 17, 2025
Trial IDNCT06435663 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

  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine
    Yiwu, Zhejiang, China
    Recruiting

Study contacts

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.