UnknownNot Applicable

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

Taiwan10 participantsStarted 2022-12

Plain-language summary

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.

Who can participate

Age range20 Years

SexFEMALE

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Inclusion criteria

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

Exclusion criteria

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

What they're measuring

Evaluation of tumour response

Timeframe: 3 month after treatment

Trial details

NCT IDNCT05569200

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12

Contact for this trial

Kai-Wen Huang, MD, PhD

+886-23123456 fangyu0429@gmail.com

View on ClinicalTrials.gov More Benign Uterine Tumor trials