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Sonoguided-microwave Uterine Myoma (myoma)

Primary Purpose

Obstetric/Gynecology

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
"Covidien" Emprint Ablation System with Thermosphere Technology
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstetric/Gynecology focused on measuring microwave, uterine myoma

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

therapy group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Reduce days in hospital
Reduce the number of hospitalization days for patients to be less than or equal to 4 days.

Full Information

First Posted
October 28, 2021
Last Updated
November 10, 2021
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05129956
Brief Title
Sonoguided-microwave Uterine Myoma
Acronym
myoma
Official Title
Efficacy Evaluation of Laparoscopic Sonoguided-microwave Uterine Myoma Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 6, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric/Gynecology
Keywords
microwave, uterine myoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
therapy group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
"Covidien" Emprint Ablation System with Thermosphere Technology
Other Intervention Name(s)
"Covidien" Emprint Percutaneous Antenna with Thermosphere Technology
Intervention Description
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
Primary Outcome Measure Information:
Title
Uterine myoma ablation
Description
The ablation range of fibroids can be reduced by 50%, measured by MRI cubic centimeter volume.
Time Frame
1 momth
Title
Improve bleeding
Description
The hemoglobin changes before and 3 months after the operation are used to evaluate the improvement of patients' bleeding problems.
Time Frame
3 momths
Secondary Outcome Measure Information:
Title
Reduce days in hospital
Description
Reduce the number of hospitalization days for patients to be less than or equal to 4 days.
Time Frame
6 momths

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng-Yu Long, Professor
Phone
+886-7-3121101
Ext
6428
Email
urolong@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng-Yu Long, Professor
Organizational Affiliation
Department of Obstetrics and Gynecology, Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng-Yu Long, Professor
Phone
+886-7-3121101
Ext
6428
Email
urolong@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Cheng-Yu Long, Professor

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The research results are clarified and then set and shared.

Learn more about this trial

Sonoguided-microwave Uterine Myoma

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