Clinical trial NCT05129956: Sonoguided-microwave Uterine Myoma
Official title: Efficacy Evaluation of Laparoscopic Sonoguided-microwave Uterine Myoma Ablation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstetric/Gynecology
Keywords: microwave
uterine myoma
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Uterine myoma ablation
timeFrame: 1 momth
measure: Improve bleeding
timeFrame: 3 momths
Secondary outcomes:
measure: Reduce days in hospital
timeFrame: 6 momths
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Study officials:
affiliation: Department of Obstetrics and Gynecology, Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
name: Cheng-Yu Long, Professor
role: PRINCIPAL_INVESTIGATOR
References: