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

NCT07235787 | Not Yet Recruiting

• 1 other identifier: Ultrasound in uterine fibroids
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Fibroids (Leiomyoma); Symptomatic Uterine Leiomyoma

Keywords

Uterine fibroids; Leiomyoma; Microwave ablation (MWA); Ultrasound-guided ablation

Outcome Measures

Primary Outcomes (1)

• Change in Uterine Fibroid Size

  Assessment of uterine fibroid dimensions (volume/diameter) measured by ultrasound imaging to evaluate the effectiveness of microwave ablation in reducing fibroid size.

  Baseline, 3 months, and 6 months post-intervention

Secondary Outcomes (2)

• Change in Menstrual Bleeding

  Baseline, 3 months, and 6 months post-intervention

• Change in Hemoglobin Level

  Baseline and 6 months post-intervention

Study Arms (1)

Microwave Ablation Treatment

EXPERIMENTAL

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.

Procedure: Ultrasound-Guided Percutaneous Microwave Thermal Ablation

Interventions

Ultrasound-Guided Percutaneous Microwave Thermal Ablation 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.

Also known as: PMTA, Microwave Ablation, MWA

Microwave Ablation Treatment

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jihad Hussien Mohamed Mahmoud: lead

Study Sites (1)

Assiut University

Asyut, Assiut Governorate, Egypt

Location

Related Publications (2)

• 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.

  PMID: 29511672 RESULT

• 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.

  PMID: 36563871 RESULT

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Nagham N Omar, Professor

CONTACT

01028820041; Nagham.omar@aun.edu.eg

Jihad H Mahmoud, Doctorate

CONTACT

01097385666; Jihadhussien734@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an unmasked study. All participants and investigators know the intervention being performed.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist

Model Details: This is described as a "prospective case series study" with all participants receiving the same intervention (microwave ablation).

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 19, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)