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

Not Applicable

Not yet recruiting

• Conditions: Benign Uterine Tumor
• Interventions: Device: Haifu Focused Ultrasound tumor therapeutic System

• Registration Number: NCT05569200
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-04
• Last Update Submitted: 2022-10-04
• Study First Posted: 2022-10-06
• Last Update Posted: 2022-10-06
• Study Start: 2022-12
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 10

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Haifu Focused Ultrasound tumor therapeutic System	Haifu Focused Ultrasound tumor therapeutic System	-

Primary Outcome Measures

Name	Time	Method
Evaluation of tumour response	3 month after treatment	Evaluation of tumour response according to the modified RECIST criteria by sequencing MR imaging

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan