The Clinical Trial About Treatment of Benign Uterus Myoma... | NCT05569200

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

NCT05569200

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Oct 6, 2022Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Benign Uterine Tumor

Interventions

Haifu Focused Ultrasound tumor therapeutic System

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2022Estimated

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Oct 4, 2022

First Submission Date that Met QC Criteria

Oct 4, 2022

First Posted Date

Oct 6, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2022

Last Update Posted Date

Oct 6, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Haifu Focused Ultrasound tumor therapeutic System	Experimental		Device: Haifu Focused Ultrasound tumor therapeutic System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Haifu Focused Ultrasound tumor therapeutic System	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of tumour response	Evaluation of tumour response according to the modified RECIST criteria by sequencing MR imaging	3 month after treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kai-Wen Huang, MD, PhD	Contact	+886-23123456	265915	fangyu0429@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei			Taiwan