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

Launched by THE FOURTH AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE · May 26, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment method called high-intensity focused ultrasound ablation (HIFUA) for women with uterine fibroids or adenomyosis, which are benign tumors in the uterus. The goal is to see if a new imaging technology called superb micro vascular imaging (SMI) is more effective than traditional methods in evaluating how well the HIFUA treatment works. Participants will receive HIFUA treatment and then have follow-up ultrasound exams at 3, 6, and 12 months after the procedure to measure the size of their fibroids or adenomyosis.

To be eligible for the trial, participants must be adult women diagnosed with uterine fibroids or adenomyosis that fit specific criteria, such as the location of the fibroids and their overall health. This trial is currently recruiting participants and aims to provide valuable information on the effectiveness of using SMI for monitoring treatment outcomes. If you choose to participate, you can expect a non-invasive treatment experience and regular check-ins to track your progress.

Gender

FEMALE

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.