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Sonoguided-microwave Uterine Myoma

NCT ID: NCT05129956

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-06

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Obstetric/Gynecology

Keywords

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microwave uterine myoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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therapy group

Group Type EXPERIMENTAL

"Covidien" Emprint Ablation System with Thermosphere Technology

Intervention Type 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

Interventions

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"Covidien" Emprint Ablation System with Thermosphere Technology

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

Intervention Type DEVICE

Other Intervention Names

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"Covidien" Emprint Percutaneous Antenna with Thermosphere Technology

Eligibility Criteria

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Inclusion Criteria

1. Women who have reached the age of 20 and have not yet menopause.
2. Myoma sizeā‰§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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cheng-Yu Long, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology, Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan

Locations

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Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Cheng-Yu Long, Professor

Role: CONTACT

Phone: +886-7-3121101

Email: [email protected]

Facility Contacts

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Cheng-Yu Long, Professor

Role: primary

Other Identifiers

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KMUHIRB-F(I)-20210131

Identifier Type: -

Identifier Source: org_study_id