Sonoguided-microwave Uterine Myoma | NCT05129956

Studies
Sonoguided-microwave Uterine Myoma

NCT05129956

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Status

Unknown status

Last Update Posted

Nov 22, 2021Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Obstetric/Gynecology

Interventions

"Covidien" Emprint Ablation System with Thermosphere Technology

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 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 6, 2021Actual

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Oct 28, 2021

First Submission Date that Met QC Criteria

Nov 10, 2021

First Posted Date

Nov 22, 2021Actual

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

Nov 10, 2021

Last Update Posted Date

Nov 22, 2021Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study mainly evaluates the resolution of uterine fibroids by microwave ablation. The medical equipment used is Ke Hui. "The Ampening ablation system is a percutaneous surgery. During laparoscopic surgery, it is directly ablated and soft, including problems that cannot be solved by partial or complete tissue ablation. "Hydrogen is used. If the expected range of ablation can be found, there is no need to wait for 3 to 6 months for ablation slowly like Haifu surgery. A fast, small, high-quality treatment that provides reference for medical treatment and helps doctors choose the most suitable treatment.

Detailed Description

A collection of 20 women suffering from uterine fibroids were treated with microwave fibroids ablation for symptoms of uterine fibroids, and they could be discharged the next day or two days after surgery. Schedule return visits and routine blood tests according to clinical needs, and follow up with ultrasound and questionnaires during routine return visits (1, 3, and 6 months) after surgery. In the third month after surgery, there will be another imaging report. Magnetic resonance imaging and blood tests are used to compare the changes of patients' fibroids, their physiological recovery status, and the degree of improvement in their quality of life.

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
therapy group	Experimental		Device: "Covidien" Emprint Ablation System with Thermosphere Technology

Interventions

Name	Type	Description	Arm Group Labels	Other Names
"Covidien" Emprint Ablation System with Thermosphere Technology	Device	The ablation time and wattage are determined according to the size of the tumor. The wattages are respectively 45W, 75W, and 100W, and the maximum time is 10 minutes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Uterine myoma ablation	The ablation range of fibroids can be reduced by 50%, measured by MRI cubic centimeter volume.	1 momth
Improve bleeding	The hemoglobin changes before and 3 months after the operation are used to evaluate the improvement of patients' bleeding problems.	3 momths

Secondary Outcomes

Measure	Description	Time Frame
Reduce days in hospital	Reduce the number of hospitalization days for patients to be less than or equal to 4 days.	6 momths

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women who have reached the age of 20 and have not yet menopause.
Myoma size≧4cm.
Patients with submucosal fmyoma or intramural myoma of the uterus.

Exclusion Criteria:

Patients with subserosal myoma.
Pregnant, breastfeeding or have menopause.
Pelvic infections, vaginitis, cervicitis or endometritis and have not been cured.
Malignant diseases of the cervix and uterus.
Abnormal reports of clinical significance in Pap smear or thin-layer cell test.
Abnormal blood coagulation function or liver and kidney function, with bleeding tendency.
There is no safe puncture treatment route.
Those who have installed intrauterine contraceptive device or Pacemaker.
Those who cannot perform vaginal ultrasound, such as those who have no sexual experience and do not accept hymen repair.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cheng-Yu Long, Professor	Contact	+886-7-3121101	6428	urolong@yahoo.com.tw

Overall Officials

Name	Affiliation	Role
Cheng-Yu Long, Professor	Department of Obstetrics and Gynecology, Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)	Recruiting	Kaohsiung City			Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

The research results are clarified and then set and shared.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D047708	Myofibroma

Ancestor Terms

ID	Term
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

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Browse Branches

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