NCT06435663 The Clinical Application of Ultramicro-flow Technique in the Treatment of Benign Uterine Tumors With High-intensity Focused Ultrasound

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This trial targets 30 participants in total. It began in 2024-12-01 with a primary completion date of 2025-12-31.

Brief Summary

High intensity focused ultrasound ablation (HIFUA) is a new non-invasive treatment method for uterine tumors. Traditionally, nuclear magnetic resonance imaging (NMRI), also known as magnetic resonance imaging (MRI), is used as guidance to focus ultrasound on the fibroid tissue, generating high temperatures of 65-85 ℃, causing protein inactivation, cell apoptosis, and coagulation necrosis of tumor cells. While accurately ablating fibroid tissue, it avoids damaging normal tissue outside the treatment area. Since 2000, a large number of clinical studies have demonstrated the safety and effectiveness of MRI for HIFUA in the treatment of uterine fibroids. In 2013, the Chinese FDA approved MRI guided HIFUA treatment for uterine fibroids. At present, more and more medical institutions in China have introduced this device and carried out non-invasive treatment of uterine fibroids. In March 2020, the Minimally Invasive Treatment Group of the Magnetic Resonance Application Professional Committee of the China Medical Equipment Association designated the "Chinese Expert for MRI Guided Focused Ultrasound Treatment of Uterine Fibroids", making HIFUA more standardized. Superb micro vascular imaging (SMI) is an improved Doppler technology that applies a new adaptive algorithm to remove tissue motion signals and blood flow overflow phenomena, and can clearly display the extremely low velocity blood flow inside the blood vessels. Previous studies have shown that SMI has a significantly higher ability to detect blood vessels in tumors than color Doppler flow imaging (CDFI), and can more sensitively detect the blood flow of microvessels within tumors. This provides a cheap and simple non-invasive examination method for clinical practice, and real-time guidance for treatment can be provided during the treatment process, making it easy to operate and promote in clinical practice. This study randomly divided all adult patients diagnosed with uterine fibroids or adenomyosis admitted to our hospital from May 2024 to December 2024 into two groups based on the inclusion and exclusion of specimens: 1) Experimental group: HIFUA treatment, treatment efficacy evaluation using SMI technology; control group: HIFUA treatment, treatment efficacy evaluation using organ contrast-enhanced ultrasound technology. Both groups of subjects need to be followed up: at 3 months, 6 months, and 12 months after treatment, patients will undergo gynecological uterine ultrasound examination at the outpatient department, and the volume of uterine fibroids or adenomyosis will be recorded. The aim of this study is to compare the accuracy data of two groups in evaluating treatment effectiveness, and to verify that ultra-fine blood flow imaging (SMI) technology is superior to organ contrast-enhanced ultrasound in evaluating the efficacy of HIFUA treatment。

Eligibility 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.

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