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Trial Title:
The Clinical Trial About Treatment of Benign Uterus Myoma by Haifu Focused Ultrasound Tumor Therapeutic System
NCT ID:
NCT05569200
Condition:
Benign Uterine Tumor
Conditions: Official terms:
Uterine Neoplasms
Leiomyoma
Myofibroma
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Haifu Focused Ultrasound tumor therapeutic System
Description:
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.
Arm group label:
Haifu Focused Ultrasound tumor therapeutic System
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Country:
Taiwan
Contact:
Last name:
Kai-Wen Huang
Phone:
+886-23123456
Phone ext:
265915
Email:
fangyu0429@gmail.com
Start date:
December 2022
Completion date:
December 2024
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05569200
