Uterine Fibroids (Leiomyoma)MWAUFNCT07235787
Efficacy of Ultrasound Guided Microwave Ablation in the Treatment of Uterine Fibroids.
A study testing Ultrasound-Guided Percutaneous Microwave Thermal Ablation in people with Uterine Fibroids (Leiomyoma) and Symptomatic Uterine Leiomyoma, run by Jihad Hussien Mohamed Mahmoud at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Uterine Fibroids (Leiomyoma), Symptomatic Uterine Leiomyoma
- What is being tested?
- Ultrasound-Guided Percutaneous Microwave Thermal Ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University
Asyut, Assiut Governorate
Jihad H Mahmoud, Doctorate, +20 1097385666 ext. 20, Jihadhussien734@med.aun.edu.eg
About this study
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.
Read more
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.
Read the 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.
- Being tested
- Ultrasound-Guided Percutaneous Microwave Thermal Ablation
- Keywords
- Uterine fibroids, Leiomyoma, Microwave ablation (MWA), Ultrasound-guided ablation
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Percutaneous Microwave Thermal AblationProcedure or surgery
Also called PMTA, Microwave Ablation, MWA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Ultrasound-Guided Percutaneous Microwave Thermal Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, and 6 months post-intervention
Secondary outcomes (2)
Change in Menstrual Bleeding
Assessment of menstrual bleeding severity measured by the number of pads/diapers used during menses and the number of days of menstruation.
Measured: Baseline, 3 months, and 6 months post-intervention
Change in Hemoglobin Level
Assessment of hemoglobin (Hb) level through complete blood count (CBC) to evaluate improvement in anemia related to fibroid-associated bleeding.
Measured: Baseline and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start30 Nov 2025 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Uterine Fibroids (Leiomyoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is described as a "prospective case series study" with all participants receiving the same intervention (microwave ablation).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jihad Hussien Mohamed Mahmoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jihad Hussien Mohamed Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235787
- Sponsor's protocol ID
- Ultrasound in uterine fibroids
- Acronym
- MWAUF
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29511672Xia 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.
PubMed 36563871
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound Guided Microwave Ablation in the Treatment of Uterine Fibroids.
- ClinicalTrials.gov ID
- NCT07235787
- Acronym / sponsor ID
- MWAUF / Ultrasound in uterine fibroids
- Keywords
- Uterine fibroids, Leiomyoma, Microwave ablation (MWA), Ultrasound-guided ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jihad Hussien Mohamed MahmoudUniversity, hospital or other
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is described as a "prospective case series study" with all participants receiving the same intervention (microwave ablation).
| Arm | Type | Receives |
|---|---|---|
| Microwave Ablation Treatment | Experimental | Procedure: Ultrasound-Guided Percutaneous Microwave Thermal AblationPatients 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Percutaneous Microwave Thermal AblationAlso: PMTA, Microwave Ablation, MWAMinimally 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. | Procedure or surgery | Microwave Ablation Treatment |
Primary outcome
Change in Uterine Fibroid Size
Time frame: Baseline, 3 months, and 6 months post-intervention
Assessment of uterine fibroid dimensions (volume/diameter) measured by ultrasound imaging to evaluate the effectiveness of microwave ablation in reducing fibroid size.
2 secondary outcomes
Change in Menstrual Bleeding
Time frame: Baseline, 3 months, and 6 months post-intervention
Change in Hemoglobin Level
Time frame: Baseline and 6 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 29511672Ierardi 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.
- Results publication: PubMed 36563871Xia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Percutaneous Microwave Thermal Ablation in people with Uterine Fibroids (Leiomyoma) and Symptomatic Uterine Leiomyoma, run by Jihad Hussien Mohamed Mahmoud at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nagham N Omar, Professor (01028820041 ext. 20, Nagham.omar@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Uterine Fibroid Size (time frame: Baseline, 3 months, and 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07235787, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.