Efficacy of Ultrasound Guided Microwave Ablation in the Treatment of Uterine Fibroids.

NCT ID: NCT07235787

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2027-12-01

Brief Summary

Uterine fibroids are the most common benign tumors of the female genital tract and can significantly affect the quality of life in reproductive-age women, causing symptoms such as heavy menstrual bleeding, pelvic pressure, urinary disturbances, dyspareunia, and infertility. Traditional surgical interventions such as myomectomy and hysterectomy remain the standard of care, yet they are associated with considerable trauma, longer recovery times, and the loss of uterine function.

Microwave ablation (MWA) is a minimally invasive image-guided technique that uses microwave energy to induce coagulative necrosis in fibroid tissue, reducing its size and alleviating symptoms while preserving the uterus. This study aims to evaluate the feasibility, safety, and therapeutic effectiveness of ultrasound-guided percutaneous microwave thermal ablation (PMTA) in the management of symptomatic uterine fibroids.

Eligible participants are premenopausal women aged 25 years or older with symptomatic fibroids less than 10 cm in size and fewer than five in number. Exclusion criteria include pregnancy, bleeding disorders, chronic diseases contraindicating anesthesia, and ongoing anticoagulant therapy.

Each participant will undergo ultrasound-guided microwave ablation under aseptic conditions and sedation. Fibroid size, menstrual bleeding patterns, hemoglobin levels, and pain scores will be evaluated at baseline and during follow-up at 3 and 6 months. The primary outcome is the reduction in fibroid size, while secondary outcomes include symptom improvement and hemoglobin level changes.

This prospective case series will be conducted at Assiut University Hospitals, Egypt, with 20 participants referred from the Gynecology Department to the Interventional Radiology Unit. The results will provide valuable data on the clinical value of MWA as a uterus-preserving alternative for symptomatic uterine fibroids.

Detailed Description

This prospective interventional study will investigate the efficacy and safety of ultrasound-guided microwave ablation (MWA) for the treatment of uterine fibroids in premenopausal women who wish to avoid hysterectomy.

Fibroids are a leading cause of gynecologic morbidity and the most common indication for hysterectomy worldwide. Although medical and surgical therapies exist, many patients experience suboptimal outcomes or prefer minimally invasive, uterus-sparing treatments. MWA offers a promising alternative, providing precise thermal destruction of fibroid tissue through localized energy deposition with minimal collateral damage.

In this study, 20 women diagnosed with symptomatic uterine fibroids meeting inclusion criteria will be recruited. After pre-procedural evaluation-including clinical assessment, imaging, and laboratory testing-patients will undergo percutaneous MWA under ultrasound guidance. A microwave needle (1.4-1.6 mm in diameter and 15-20 cm in length) will be inserted into the fibroid, and thermal ablation will be applied for 10-30 minutes depending on lesion characteristics.

Post-procedure monitoring will include ultrasound assessment for immediate complications, with follow-up visits at 3 and 6 months to evaluate changes in fibroid size, menstrual characteristics, pain, and hemoglobin levels.

Statistical analysis will include descriptive measures and comparative tests (chi-square, t-test, or Wilcoxon rank-sum). Significance will be set at p ≤ 0.05. Data will be analyzed using STATA 13.

The study is conducted in compliance with the Declaration of Helsinki and has received ethical approval from the Assiut University Faculty of Medicine Ethics Committee. Written informed consent will be obtained from all participants prior to inclusion.

The expected outcome is to demonstrate that ultrasound-guided MWA is a feasible, safe, and effective minimally invasive therapy for uterine fibroids, potentially improving patient quality of life while avoiding the morbidity associated with hysterectomy and other surgical interventions.

Conditions

Uterine Fibroids (Leiomyoma); Symptomatic Uterine Leiomyoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Microwave Ablation Treatment

Patients with symptomatic uterine fibroids who meet inclusion criteria will undergo ultrasound-guided percutaneous microwave thermal ablation (PMTA). The procedure involves percutaneous insertion of a microwave needle (1.4 to 1.6mm diameter and 15 to 20 cm length) into the fibroid under US guidance, with thermal ablation continuing for 10 to 30 minutes under IV sedation. Patients will be followed at 3 and 6 months to assess fibroid size reduction and symptom improvement.

Group Type: EXPERIMENTAL

Ultrasound-Guided Percutaneous Microwave Thermal Ablation

Intervention Type: PROCEDURE

Minimally invasive percutaneous microwave thermal ablation of symptomatic uterine fibroids performed under ultrasound guidance. After 8 hours fasting and under aseptic conditions with IV sedation, a microwave needle (1.4-1.6mm diameter, 15-20cm length depending on fibroid site and size) is inserted percutaneously into the fibroid under ultrasound guidance. Thermal ablation is performed for 10-30 minutes to achieve coagulation necrosis of the fibroid tissue. Patients are discharged after several hours with post-procedure antibiotics and analgesics. Follow-up assessments at 3 and 6 months include ultrasound imaging, hemoglobin levels, and symptom evaluation.

Interventions

Ultrasound-Guided Percutaneous Microwave Thermal Ablation

Minimally invasive percutaneous microwave thermal ablation of symptomatic uterine fibroids performed under ultrasound guidance. After 8 hours fasting and under aseptic conditions with IV sedation, a microwave needle (1.4-1.6mm diameter, 15-20cm length depending on fibroid site and size) is inserted percutaneously into the fibroid under ultrasound guidance. Thermal ablation is performed for 10-30 minutes to achieve coagulation necrosis of the fibroid tissue. Patients are discharged after several hours with post-procedure antibiotics and analgesics. Follow-up assessments at 3 and 6 months include ultrasound imaging, hemoglobin levels, and symptom evaluation.

Intervention Type: PROCEDURE

Other Intervention Names

PMTA; Microwave Ablation; MWA

Eligibility Criteria

Inclusion Criteria

Female patients aged 25 years or older Good general health Symptomatic uterine fibroids suitable for microwave ablation as determined by examining gynecologist Premenopausal status Acceptable risks for general anesthesia or sedation Number of fibroids: fewer than 5 Size of fibroid: less than 10 cm

Exclusion Criteria

Ongoing anticoagulant treatment and/or known bleeding disorder Chronic diseases contraindicating general anesthesia Pregnancy Postmenopausal status 5 or more fibroids Fibroid size 10 cm or larger Poor general health precluding anesthesia or sedation

• Minimum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jihad Hussien Mohamed Mahmoud

OTHER

Sponsor Role: lead

Responsible Party

Jihad Hussien Mohamed Mahmoud

Specialist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Assiut University

Asyut, Assiut Governorate, Egypt

Countries

Egypt

Central Contacts

Nagham N Omar, Professor

Role: CONTACT

Nagham.omar@aun.edu.eg

01028820041 ext. 20

Jihad H Mahmoud, Doctorate

Role: CONTACT

Jihadhussien734@med.aun.edu.eg

01097385666 ext. 20

Facility Contacts

Jihad H Mahmoud, Doctorate

Role: primary

Jihadhussien734@med.aun.edu.eg

+20 1097385666 ext. 20

References

Ierardi AM, Savasi V, Angileri SA, Petrillo M, Sbaraini S, Pinto A, Hanozet F, Marconi AM, Carrafiello G. Percutaneous High Frequency Microwave Ablation of Uterine Fibroids: Systematic Review. Biomed Res Int. 2018 Jan 8;2018:2360107. doi: 10.1155/2018/2360107. eCollection 2018.

Reference Type: RESULT

PMID: 29511672 (View on PubMed)

Xia J, Teng D, Sui G, Luo Q, Lin Y, Wang H. Effectiveness and Safety of Ultrasound-guided Percutaneous Microwave Ablation for a Single Uterine Fibroid Greater than 300 cm3. J Minim Invasive Gynecol. 2023 Apr;30(4):290-299. doi: 10.1016/j.jmig.2022.12.013. Epub 2022 Dec 20.

Reference Type: RESULT

PMID: 36563871 (View on PubMed)

Other Identifiers

Ultrasound in uterine fibroids

Identifier Type: -

Identifier Source: org_study_id