The Clinical Trial About Treatment of Benign Uterus Myoma by Haifu Focused Ultrasound Tumor Therapeutic System

National Taiwan University

Status: Not yet enrolling

Conditions: Benign Uterine Tumor

Treatments: Device: Haifu Focused Ultrasound tumor therapeutic System

Study type: Interventional

Funder types: Other

Identifiers

NCT05569200

202111052RIPC

Details and patient eligibility

About

Uterine benign tumor including myoma is the most common female benign pelvic tumor. Magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) has been considered to be a minimal invasive treatment. The device used in this trial will be Haifu Focused Ultrasound tumor therapeutic System. In this trial, the investigators will observe the possibility of complication and tumor response of treatment.

Enrollment: 10 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Benign uterine fibroids.
2. Women over the age of 20.
3. Abdominal circumference <100 cm.
4. The largest fibroids are ≥ 4 cm.

Exclusion criteria

1. Pregnant women or those with positive pregnancy test results.
2. Those with other pelvic diseases.
3. Those with immune diseases.
4. There are unsuitable interfaces in the ultrasonic treatment path.
5. Those with tumor calcification.
6. People with severe heart, blood vessel and kidney disease.
7. Those with abnormal coagulation function and low platelets.
8. Type III fibroids according to Funaki classification

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Haifu Focused Ultrasound tumor therapeutic System

Experimental group

Treatment:

Device: Haifu Focused Ultrasound tumor therapeutic System