The Clinical Trial About Treatment of Benign Uterus Myoma by Haifu Focused Ultrasound Tumor Therapeutic System
Primary Purpose
Benign Uterine Tumor
Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Haifu Focused Ultrasound tumor therapeutic System
Sponsored by
About this trial
This is an interventional treatment trial for Benign Uterine Tumor
Eligibility Criteria
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
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Haifu Focused Ultrasound tumor therapeutic System
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of tumour response
Evaluation of tumour response according to the modified RECIST criteria by sequencing MR imaging
Secondary Outcome Measures
Full Information
NCT ID
NCT05569200
First Posted
October 4, 2022
Last Updated
October 4, 2022
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05569200
Brief Title
The Clinical Trial About Treatment of Benign Uterus Myoma by Haifu Focused Ultrasound Tumor Therapeutic System
Official Title
The Clinical Trial About Treatment of Benign Uterus Myoma by Haifu Focused Ultrasound Tumor Therapeutic System.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Uterine Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Haifu Focused Ultrasound tumor therapeutic System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Haifu Focused Ultrasound tumor therapeutic System
Intervention 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.
Primary Outcome Measure Information:
Title
Evaluation of tumour response
Description
Evaluation of tumour response according to the modified RECIST criteria by sequencing MR imaging
Time Frame
3 month after treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai-Wen Huang, MD, PhD
Phone
+886-23123456
Ext
265915
Email
fangyu0429@gmail.com
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai-Wen Huang
Phone
+886-23123456
Ext
265915
Email
fangyu0429@gmail.com
12. IPD Sharing Statement
Learn more about this trial
The Clinical Trial About Treatment of Benign Uterus Myoma by Haifu Focused Ultrasound Tumor Therapeutic System
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