Non-invasive treatment for benign uterine tumors using focused ultrasound
Fellow Docotor, Master's Degree
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine Academic / other |
| Locations | 1 site (Yiwu, Zhejiang) |
| Trial ID | NCT06435663 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult women diagnosed with uterine fibroids or adenomyosis who meet specific imaging and health criteria.
Not a fit: Patients with rapidly growing fibroids, unclear diagnoses, or significant health issues may not benefit from this treatment.
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 performed: Previous studies have shown the safety and effectiveness of MRI-guided HIFUA for treating uterine fibroids, indicating a promising approach.
Eligibility criteria
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 this trial is running
Yiwu, Zhejiang
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.