Sonoguided-microwave Uterine Myoma

Not Applicable

Recruiting

• Conditions: Obstetric/Gynecology
• Interventions: Device: "Covidien" Emprint Ablation System with Thermosphere Technology

• Registration Number: NCT05129956
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Study Timeline

• Study Start: 2021-08-06
• Status Verified: 2021-10
• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-11-10
• Last Update Submitted: 2021-11-10
• Study First Posted: 2021-11-22
• Last Update Posted: 2021-11-22
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
therapy group	"Covidien" Emprint Ablation System with Thermosphere Technology	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH); 🇨🇳 Kaohsiung, Taiwan