ArticleGynecological surgery
Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate® System: three- and six-month endpoint results from the FAST-EU study.
Article in Gynecological surgery. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 4 of them syntheses that pooled it.
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The trial behind it
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Who cites it
23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 43 citations in OpenAlex.
- A Systematic Review of Minimally Invasive Approaches to Uterine Fibroid Treatment for Improving Quality of Life and Fibroid-Associated Symptoms.Reproductive sciences (Thousand Oaks, Calif.) · 2023Pooled it
- A Systematic Review of Minimally Invasive Treatments for Uterine Fibroid-Related Bleeding.Reproductive sciences (Thousand Oaks, Calif.) · 2022Pooled it
- Pictorial methods to assess heavy menstrual bleeding in research and clinical practice: a systematic literature review.BMC women's health · 2020Pooled it
- Clinical Performance of Radiofrequency Ablation for Treatment of Uterine Fibroids: Systematic Review and Meta-Analysis of Prospective Studies.Journal of laparoendoscopic & advanced surgical techniques. Part A · 2019Pooled it
- Postpartum Management of Placenta Accreta with Transcervical Radiofrequency Ablation for Fertility Conservation.Journal of clinical medicine · 2026Article
- Hysteroscopic diode laser myolysis: from a case series to literature review of incisionless myolysis techniques for managing heavy menstrual bleeding in premenopausal women.Archives of gynecology and obstetrics · 2024Review
- Delayed expulsion of a large fibroid after transcervical radiofrequency ablation: A case report.Radiology case reports · 2023Article
- Long-term results of transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the Sonata System: a retrospective follow-up study.AJOG global reports · 2022Article
- Pregnancy Outcomes After Transcervical Radiofrequency Ablation of Uterine Fibroids with the Sonata System.Journal of gynecologic surgery · 2022Article
- Combined procedure of the transcervical radiofrequency ablation (TRFA) system and surgical hysteroscopy. Increased risk or safe procedure?Wideochirurgia i inne techniki maloinwazyjne = Videosurgery and other miniinvasive techniques · 2022Article
- A feasibility analysis of the ArcBlate MR-guided high-intensity focused ultrasound system for the ablation of uterine fibroids.Abdominal radiology (New York) · 2021Article
- Transcervical fibroid ablation with the Sonata™ system for treatment of submucous and large uterine fibroids.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2021Article
- The CHOICES Study: Facility Level Comparative Cost, Resource Utilization, and Outcomes Analysis of Myomectomy Compared to Transcervical Fibroid Ablation.ClinicoEconomics and outcomes research : CEOR · 2020Article
- Transcervical Radiofrequency Ablation of Symptomatic Uterine Fibroids: 2-Year Results of the SONATA Pivotal Trial.Journal of gynecologic surgery · 2019Article
- The INTEGRITY Trial: Preservation of Uterine-Wall Integrity 12 Months After Transcervical Fibroid Ablation with the Sonata System.Journal of gynecologic surgery · 2019Article
- Term Delivery in an Infertile Patient after Transcervical Radiofrequency Fibroid Ablation and Assisted Reproductive Technology.Journal of gynecologic surgery · 2019Article
- Long-Term Clinical Outcomes of Transcervical Radiofrequency Ablation of Uterine Fibroids: The VITALITY Study.Journal of gynecologic surgery · 2019Article
- 12-month outcomes of the US patient cohort in the SONATA pivotal IDE trial of transcervical ablation of uterine fibroids.International journal of women's health · 2019Article
- A New Paradigm for Uterine Fibroid Treatment: Transcervical, Intrauterine Sonography-Guided Radiofrequency Ablation of Uterine Fibroids with the Sonata System.Current obstetrics and gynecology reports · 2017Review
- Ultrasound-guided transcervical radiofrequency ablation for symptomatic uterine adenomyosis.The British journal of radiology · 2017Article
Corrections and comments
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Authors and funding
5 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This was a prospective, longitudinal, multicenter, single-arm controlled trial, using independent core laboratory validation of MRI results, to establish the effectiveness and confirm the safety of the VizAblate® System in the treatment of symptomatic uterine fibroids. The VizAblate System is a transcervical device that ablates fibroids with radiofrequency energy, guided by a built-in intrauterine ultrasound probe. Fifty consecutive women with symptomatic uterine fibroids received treatment with the VizAblate System. Patients had a minimum Menstrual Pictogram score of 120, no desire for fertility, and met additional inclusion and exclusion criteria. The VizAblate System was inserted transcervically and individual fibroids were ablated with radiofrequency energy. An integrated intrauterine ultrasound probe was used for fibroid imaging and targeting. Anesthesia was at the discretion of each investigator. The primary study endpoint was the percentage change in perfused fibroid volume, as assessed by contrast-enhanced MRI at 3 months. Secondary endpoints, reached at 6 months, included safety, percentage reductions in the Menstrual Pictogram (MP) score and the Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom-Quality of Life questionnaire (UFS-QOL), along with the rate of surgical reintervention for abnormal uterine bleeding and the mean number of days to return to normal activity. Additional assessments included the Health-Related Quality of Life (HRQOL) subscale of the UFS-QOL, medical reintervention for abnormal uterine bleeding, and procedure times. Fifty patients were treated, representing 92 fibroids. Perfused fibroid volumes were reduced at 3 months by an average of 68.8 ± 27.8 % (
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.