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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
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Uterine Tumor

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

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

First Posted
October 4, 2022
Last Updated
October 4, 2022
Sponsor
National Taiwan University Hospital
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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

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

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