Leiomyoma (Uterine Fibroids)NCT07923253
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
A study testing Radiofrequency ablation alone in people with Leiomyoma (Uterine Fibroids), run by University of Novi Sad at 1 site in Serbia.
Trial summary
This study evaluates the effectiveness and safety of transvaginal radiofrequency ablation of myomas (TVRFAM), a minimally invasive treatment for uterine fibroids performed at our clinic as part of the study. Women with uterine fibroids who meet the study eligibility criteria are invited to participate. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Leiomyoma (Uterine Fibroids)
- What is being tested?
- Radiofrequency ablation alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSerbia
- Study dates
- 15 Apr 2024to Jan 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adult women (18 years of age or older).
- Women with uterine fibroids classified as FIGO types 3-5
- Uterine fibroids measuring 2-10 cm in diameter.
- Ability and willingness to provide written informed consent.
Who cannot join
- Women younger than 18 years of age.
- Postmenopausal women.
- Pregnant women.
- Uterine fibroids outside the eligible FIGO types (3-5) or size range (2-10 cm in diameter).
- Uterine fibroids with suspicious imaging features suggestive of uterine sarcoma.
- Known or suspected gynecological malignancy or premalignant gynecological conditions.
- Presence of an intrauterine device (IUD).
- Active pelvic infection.
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Clinic for Gynecology and Obstetrics, University Clinical Center of Vojvodina, Novi Sad, Serbia
Novi Sad, 21000
About this study
Official title: Prospective Interventional Study Evaluating Fibroid Volume Reduction, Quality of Life, and Safety Following Transvaginal Radiofrequency Ablation of FIGO Type 3-5 Uterine Fibroids
This study evaluates the effectiveness and safety of transvaginal radiofrequency ablation of myomas (TVRFAM), a minimally invasive treatment for uterine fibroids performed at our clinic as part of the study.
Women with uterine fibroids who meet the study eligibility criteria are invited to participate. The study includes women with fibroids classified as FIGO types 3-5, measuring 2-10 cm in diameter. Up to three fibroids may be treated during a single procedure. Written informed consent is obtained from all participants before enrollment.
Read more
Before treatment, participants complete the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire, which assesses fibroid-related symptoms and their impact on daily life.
Participants are followed for 12 months after treatment, with follow-up visits at 1, 3, 6, and 12 months. At each visit, a transvaginal ultrasound examination is performed to measure the volume of the treated fibroids. Participants also complete the UFS-QOL questionnaire to assess changes in their symptoms and quality of life over time.
Complications occurring during the procedure are recorded. Information on pain after treatment, the duration of pain-relieving medication use, and any postoperative complications or other unwanted effects is also collected during follow-up.
The main aim of the study is to measure the percentage reduction in fibroid volume following treatment. The study also evaluates changes in symptoms and quality of life, pain after the procedure, use of pain-relieving medication, and any complications or unwanted effects during the 12-month follow-up period.
- Conditions
- Leiomyoma (Uterine Fibroids)
- Being tested
- Radiofrequency ablation alone
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation aloneProcedure or surgery
Transvaginal radiofrequency ablation of uterine myomas (TVRFAm) is performed in sedated patients in the lithotomy and Trendelenburg position using the STARMED VIVA RF system and a single 17G bipolar cooled radiofrequency electrode under continuous real-time transvaginal ultrasound guidance.
The electrode is introduced transvaginally with the active tip maintained approximately 0.5 cm from the fibroid wall. Ablation is performed at 100 W using the moving-shot technique, with sequential repositioning of the electrode into untreated areas. Active tip lengths of 10 mm, 20 mm, or an adjustable 5-30 mm length are selected according to fibroid size. Each application lasts approximately 5-10 seconds. When tissue impedance exceeds 100 Ohms, the electrode is withdrawn or repositioned to another unablated area. The procedure induces thermal coagulative necrosis of the fibroid tissue, followed by gradual resorption and volume reduction.
| Study group | Role | What they receive |
|---|---|---|
| TVRFAM Treatment | Experimental | Participants with FIGO type 3-5 uterine fibroids measuring 2-10 cm undergo transvaginal radiofrequency ablation of myomas (TVRFAM). Up to three fibroids are treated during a single procedure. Participants are followed for 12 months to assess fibroid volume reduction, changes in quality of life, procedure-related pain, analgesic use, and complications or other adverse events. Receives: Procedure: Radiofrequency ablation alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in fibroid volume at 6 months after the intervention
Change in uterine fibroid volume from baseline to 6 months after the intervention will be assessed by ultrasound and calculated as:
[(fibroid volume at 6 months - baseline fibroid volume) / baseline fibroid volume] × 100.
Measured: 6 months after the procedure
Secondary outcomes (15)
Percentage change in fibroid volume at 1 month after the intervention
Change in uterine fibroid volume from baseline to 1 month after the intervention will be assessed by ultrasound and calculated as:
[(fibroid volume at 1 month - baseline fibroid volume) / baseline fibroid volume] × 100.
Measured: 1 months after the procedure
Percentage change in fibroid volume at 3 months after the intervention
Change in uterine fibroid volume from baseline to 3 months after the intervention will be assessed by ultrasound and calculated as:
[(fibroid volume at 3 months - baseline fibroid volume) / baseline fibroid volume] × 100.
Measured: 3 months after the procedure
Percentage change in fibroid volume at 12 months after the intervention
Change in uterine fibroid volume from baseline to 12 months after the intervention will be assessed by ultrasound and calculated as:
[(fibroid volume at 12 months - baseline fibroid volume) / baseline fibroid volume] × 100.
Measured: 12 months after the procedure
Change in uterine fibroid Symptom Severity Score (SSS)
Change from baseline in uterine fibroid symptom severity will be assessed using the Symptom Severity Score (SSS) of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire. The score will be calculated according to the scoring algorithm and expressed on a scale of 0-100, with higher scores indicating greater symptom severity.
Measured: Baseline, 1, 3, 6, and 12 months after the intervention.
Change in Overall Health-Related Quality of Life (HRQOL) Score
Change from baseline in health-related quality of life will be assessed using the overall Health-Related Quality of Life (HRQOL) score of the UFS-QOL questionnaire. The score will be calculated according to the scoring algorithm and expressed on a scale of 0-100, with higher scores indicating better health-related quality of life
Measured: Baseline, 1, 3, 6, and 12 months after the intervention.
Change in UFS-QOL Concern Domain Score
Change from baseline in the Concern domain score will be assessed using the corresponding domain of the UFS-QOL questionnaire. The score will be calculated according to the scoring algorithm and expressed on a scale of 0-100, with higher scores indicating better health-related quality of life.
Measured: Baseline, 1, 3, 6, and 12 months after the intervention.
Change in UFS-QOL Activities Domain Score
Change from baseline in the Activities domain score will be assessed using the corresponding domain of the UFS-QOL questionnaire. The score will be calculated according to the scoring algorithm and expressed on a scale of 0-100, with higher scores indicating better health-related quality of life.
Measured: Baseline, 1, 3, 6, and 12 months after the intervention.
Change in UFS-QOL Energy/Mood Domain Score
Change from baseline in the Energy/Mood domain score will be assessed using the corresponding domain of the UFS-QOL questionnaire. The score will be calculated according to the scoring algorithm and expressed on a scale of 0-100, with higher scores indicating better health-related quality of life.
Measured: Baseline, 1, 3, 6, and 12 months after the intervention.
Change in UFS-QOL Control Domain Score
Change from baseline in the Control domain score will be assessed using the corresponding domain of the UFS-QOL questionnaire. The score will be calculated according to the scoring algorithm and expressed on a scale of 0-100, with higher scores indicating better health-related quality of life.
Measured: Baseline, 1, 3, 6, and 12 months after the intervention.
Change in UFS-QOL Self-Consciousness Domain Score
Change from baseline in the Self-Consciousness domain score will be assessed using the corresponding domain of the UFS-QOL questionnaire. The score will be calculated according to the scoring algorithm and expressed on a scale of 0-100, with higher scores indicating better health-related quality of life.
Measured: Baseline, 1, 3, 6, and 12 months after the intervention.
Change in UFS-QOL Sexual Function Domain Score
Change from baseline in the Sexual Function domain score will be assessed using the corresponding domain of the UFS-QOL questionnaire. The score will be calculated according to the scoring algorithm and expressed on a scale of 0-100, with higher scores indicating better health-related quality of life.
Measured: Baseline, 1, 3, 6, and 12 months after the intervention.
Incidence of Intraoperative and Postoperative Complications
The occurrence of intraoperative and early postoperative complications will be recorded. Participants will be asked at the 1-month follow-up visit to report any complications that occurred during the intervention or within the first month after the intervention.
Measured: From the start of the intervention through 1 month after the intervention.
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), based on the participant's assessment of pain experienced after the intervention.
Measured: At the first postoperative follow-up visit.
Duration of Postoperative Analgesic Use
The number of days of analgesic use following the intervention will be recorded.
Measured: From the day of the intervention until discontinuation of analgesic use, as reported at the first postoperative follow-up visit.
Achievement of Pregnancy in Participants With Infertility
Among participants with infertility who are attempting to conceive, achievement of pregnancy during the follow-up period will be recorded. This outcome will be reported descriptively and is not intended to establish a causal effect of the intervention on fertility.
Measured: From the intervention until 12 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start15 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leiomyoma (Uterine Fibroids)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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jelena Vuković, University of Novi Sad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923253
- Sponsor's protocol ID
- EA No 00-125/13.04.2024.
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Interventional Study Evaluating Fibroid Volume Reduction, Quality of Life, and Safety Following Transvaginal Radiofrequency Ablation of FIGO Type 3-5 Uterine Fibroids
- ClinicalTrials.gov ID
- NCT07923253
- Acronym / sponsor ID
- EA No 00-125/13.04.2024.
- Conditions
- Leiomyoma (Uterine Fibroids)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Novi SadUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 6 Nov 2026 (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.
This study evaluates the effectiveness and safety of transvaginal radiofrequency ablation of myomas (TVRFAM), a minimally invasive treatment for uterine fibroids performed at our clinic as part of the study.
Women with uterine fibroids who meet the study eligibility criteria are invited to participate. The study includes women with fibroids classified as FIGO types 3-5, measuring 2-10 cm in diameter. Up to three fibroids may be treated during a single procedure. Written informed consent is obtained from all participants before enrollment.
Before treatment, participants complete the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire, which assesses fibroid-related symptoms and their impact on daily life.
Participants are followed for 12 months after treatment, with follow-up visits at 1, 3, 6, and 12 months. At each visit, a transvaginal ultrasound examination is performed to measure the volume of the treated fibroids. Participants also complete the UFS-QOL questionnaire to assess changes in their symptoms and quality of life over time.
Complications occurring during the procedure are recorded. Information on pain after treatment, the duration of pain-relieving medication use, and any postoperative complications or other unwanted effects is also collected during follow-up.
The main aim of the study is to measure the percentage reduction in fibroid volume following treatment. The study also evaluates changes in symptoms and quality of life, pain after the procedure, use of pain-relieving medication, and any complications or unwanted effects during the 12-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TVRFAM Treatment | Experimental | Procedure: Radiofrequency ablation aloneParticipants with FIGO type 3-5 uterine fibroids measuring 2-10 cm undergo transvaginal radiofrequency ablation of myomas (TVRFAM). Up to three fibroids are treated during a single procedure. Participants are followed for 12 months to assess fibroid volume reduction, changes in quality of life, procedure-related pain, analgesic use, and complications or other adverse events. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult women (18 years of age or older).
- Women with uterine fibroids classified as FIGO types 3-5
- Uterine fibroids measuring 2-10 cm in diameter.
- Ability and willingness to provide written informed consent.
Key exclusion criteria (8 listed)
- Women younger than 18 years of age.
- Postmenopausal women.
- Pregnant women.
- Uterine fibroids outside the eligible FIGO types (3-5) or size range (2-10 cm in diameter).
- Uterine fibroids with suspicious imaging features suggestive of uterine sarcoma.
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 |
|---|---|---|
| Radiofrequency ablation aloneTransvaginal radiofrequency ablation of uterine myomas (TVRFAm) is performed in sedated patients in the lithotomy and Trendelenburg position using the STARMED VIVA RF system and a single 17G bipolar cooled radiofrequency electrode under continuous real-time transvaginal ultrasound guidance. The electrode is introduced transvaginally with the active tip maintained approximately 0.5 cm from the fibroid wall. Ablation is performed at 100 W using the moving-shot technique, with sequential repositioning of the electrode into untreated areas. Active tip lengths of 10 mm, 20 mm, or an adjustable 5-30 mm length are selected according to fibroid size. Each application lasts approximately 5-10 seconds. When tissue impedance exceeds 100 Ohms, the electrode is withdrawn or repositioned to another unablated area. The procedure induces thermal coagulative necrosis of the fibroid tissue, followed by gradual resorption and volume reduction. | Procedure or surgery | TVRFAM Treatment |
Primary outcome
Percentage change in fibroid volume at 6 months after the intervention
Time frame: 6 months after the procedure
Change in uterine fibroid volume from baseline to 6 months after the intervention will be assessed by ultrasound and calculated as: [(fibroid volume at 6 months - baseline fibroid volume) / baseline fibroid volume] × 100.
15 secondary outcomes
Percentage change in fibroid volume at 1 month after the intervention
Time frame: 1 months after the procedure
Percentage change in fibroid volume at 3 months after the intervention
Time frame: 3 months after the procedure
Percentage change in fibroid volume at 12 months after the intervention
Time frame: 12 months after the procedure
Change in uterine fibroid Symptom Severity Score (SSS)
Time frame: Baseline, 1, 3, 6, and 12 months after the intervention.
Change in Overall Health-Related Quality of Life (HRQOL) Score
Time frame: Baseline, 1, 3, 6, and 12 months after the intervention.
Change in UFS-QOL Concern Domain Score
Time frame: Baseline, 1, 3, 6, and 12 months after the intervention.
Change in UFS-QOL Activities Domain Score
Time frame: Baseline, 1, 3, 6, and 12 months after the intervention.
Change in UFS-QOL Energy/Mood Domain Score
Time frame: Baseline, 1, 3, 6, and 12 months after the intervention.
Change in UFS-QOL Control Domain Score
Time frame: Baseline, 1, 3, 6, and 12 months after the intervention.
Change in UFS-QOL Self-Consciousness Domain Score
Time frame: Baseline, 1, 3, 6, and 12 months after the intervention.
Change in UFS-QOL Sexual Function Domain Score
Time frame: Baseline, 1, 3, 6, and 12 months after the intervention.
Incidence of Intraoperative and Postoperative Complications
Time frame: From the start of the intervention through 1 month after the intervention.
Postoperative Pain Intensity
Time frame: At the first postoperative follow-up visit.
Duration of Postoperative Analgesic Use
Time frame: From the day of the intervention until discontinuation of analgesic use, as reported at the first postoperative follow-up visit.
Achievement of Pregnancy in Participants With Infertility
Time frame: From the intervention until 12 months after the 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 6 Nov 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation alone in people with Leiomyoma (Uterine Fibroids), run by University of Novi Sad at 1 site in Serbia.
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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. 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 Serbia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in fibroid volume at 6 months after the intervention (time frame: 6 months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2026.