Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
NCT07923253, Not applicable, Active not recruiting, University of Novi Sad
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids | ClinicalTrials.gov |
| NCT number | NCT07923253 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Novi Sad | ClinicalTrials.gov |
| Conditions | Leiomyoma (Uterine Fibroids) | ClinicalTrials.gov |
| Interventions | Radiofrequency ablation alone | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Percentage change in fibroid volume at 6 months after the intervention | 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. | ClinicalTrials.gov |
| Secondary | Percentage change in fibroid volume at 1 month after the intervention | 1 months after the procedure | 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. | ClinicalTrials.gov |
| Secondary | Percentage change in fibroid volume at 3 months after the intervention | 3 months after the procedure | 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. | ClinicalTrials.gov |
| Secondary | Percentage change in fibroid volume at 12 months after the intervention | 12 months after the procedure | 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. | ClinicalTrials.gov |
| Secondary | Change in uterine fibroid Symptom Severity Score (SSS) | Baseline, 1, 3, 6, and 12 months after the intervention. | 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. | ClinicalTrials.gov |
| Secondary | Change in Overall Health-Related Quality of Life (HRQOL) Score | Baseline, 1, 3, 6, and 12 months after the intervention. | 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 | ClinicalTrials.gov |
| Secondary | Change in UFS-QOL Concern Domain Score | Baseline, 1, 3, 6, and 12 months after the intervention. | 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. | ClinicalTrials.gov |
| Secondary | Change in UFS-QOL Activities Domain Score | Baseline, 1, 3, 6, and 12 months after the intervention. | 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. | ClinicalTrials.gov |
| Secondary | Change in UFS-QOL Energy/Mood Domain Score | Baseline, 1, 3, 6, and 12 months after the intervention. | 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. | ClinicalTrials.gov |
| Secondary | Change in UFS-QOL Control Domain Score | Baseline, 1, 3, 6, and 12 months after the intervention. | 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. | ClinicalTrials.gov |
| Secondary | Change in UFS-QOL Self-Consciousness Domain Score | Baseline, 1, 3, 6, and 12 months after the intervention. | 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. | ClinicalTrials.gov |
| Secondary | Change in UFS-QOL Sexual Function Domain Score | Baseline, 1, 3, 6, and 12 months after the intervention. | 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. | ClinicalTrials.gov |
| Secondary | Incidence of Intraoperative and Postoperative Complications | From the start of the intervention through 1 month after the intervention. | 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. | ClinicalTrials.gov |
| Secondary | Postoperative Pain Intensity | At the first postoperative follow-up visit. | Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), based on the participant's assessment of pain experienced after the intervention. | ClinicalTrials.gov |
| Secondary | Duration of Postoperative Analgesic Use | From the day of the intervention until discontinuation of analgesic use, as reported at the first postoperative follow-up visit. | The number of days of analgesic use following the intervention will be recorded. | ClinicalTrials.gov |
| Secondary | Achievement of Pregnancy in Participants With Infertility | From the intervention until 12 months after the intervention. | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)