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

National Taiwan University Hospital10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Benign Uterine Tumor

Interventions

Haifu Focused Ultrasound tumor therapeutic SystemDEVICE

The device used in this trial will be Haifu Focused Ultrasound tumor therapeutic System. In Uterine benign tumor female, the investigators will observe the possibility of complication and tumor response of treatment.

Eligibility

Sex: FEMALEMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

Evaluation of tumour response

Evaluation of tumour response according to the modified RECIST criteria by sequencing MR imaging

Time frame: 3 month after treatment

Central Contacts

Kai-Wen Huang, MD, PhD

CONTACT

+886-23123456 fangyu0429@gmail.com

Data from ClinicalTrials.gov

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