An interventional study of Radiofrequency ablation alone in Leiomyoma (Uterine Fibroids), sponsored by University of Novi Sad. Active, not recruiting at 1 site in Serbia. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by University of Novi Sad · Not applicable, Interventional, and Treatment
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.
438 studies on the registry are indexed under Leiomyoma; 74 are open to participants now.
This study's planned enrollment of 50 is below the median of 66 across 306 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →University of Novi Sad is the lead sponsor of 28 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Radiofrequency ablation alone
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.
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.
Time frame: 6 months after the procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: From the intervention until 12 months after the intervention.
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Novi Sad