Clinical trial · Interventional
Fibroid Ablation Study
Symptom Effectiveness Study of VizAblate™ Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Uterine Fibroids
NCT01226290CI-TRIAL-00017368FAST-EUterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigational device changes; adequate enrollment achieved
Summary
Brief summary (as posted)
The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
| Menorrhagia | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VizAblate System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VizAblate treatment
- description
- VizAblate System: subject acts as her own control
- interventionNames
- Device: VizAblate System
Primary outcomes (1)
- measure
- Mean percentage change in target fibroid perfused volume
- timeFrame
- 3 months
Secondary outcomes (5)
- measure
- Number of adverse events
- timeFrame
- procedure through 12 mo
- description
- Procedure safety will be assessed by recording all adverse events that occur on the day of the procedure. Longer-term safety will be assessed by recording at each follow-up visit any untoward medical occurrence since baseline. Each adverse event will be assessed for severity and relationship to study device.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 28 Years
Show eligibility criteria text
Inclusion Criteria: * 28 years of age or older * Regular, consistent menstrual cycles * History of excessive bleeding * One Menstrual Pictogram score ≥ 120 during a one-month screening period * Baseline Uterine Fibroid Symptom \& Quality of Life (UFS-QOL) Symptom Severity Subscale (SSS) score ≥ 20 * Between 1 and 5 Target Fibroids between 1 cm and 5 cm and/or maximum volume 82.4cc * At least one fibroid must indent the endometrium * Subject is not at material risk for pregnancy. * Subject is willing to maintain use or non-use of hormonal contraception * Subject is willing to have uniform maintenance (use or non-use) of any antifibrinolytic or nonsteroidal anti-inflammatory agents Exclusion Criteria: * Subserosal fibroids with bulk symptoms * Presence of type 0 intracavitary fibroids * Any Target Fibroid \> 5 cm in maximum diameter with a volume \> 82.4cc * Any fibroid that obstructs access of the VizAblate probe * Postmenopausal by history * Desire for current or future fertility * Hemoglobin \< 6 g/dl * Pregnancy * Evidence of disorders of hemostasis * Use of Gonadotropin-releasing hormone (GnRH) agonist or implantable or injectable progestin and/or estrogen, Selective Estrogen Receptor Modulators (SERM) or selective progesterone receptor modulator (SPRM) * Short-term use of hormonal medication for management of bleeding * Evidence for current cervical dysplasia * Endometrial hyperplasia * Confirmed abdominal / pelvic malignancy within the previous five years * Active pelvic infection * Clinically significant adenomyosis * Previous uterine artery embolization. Previous surgical or ablative treatment for fibroids or menorrhagia within previous 12 months * Current use of anticoagulant therapy * Need for emergency surgery to treat fibroid symptoms * Concomitant intrauterine polyps \> 1.0 cm * Contraindication to MRI * Renal insufficiency * Uncontrolled hypertension lasting 2 years or more * One or more treatable fibroids that are calcified * Chronic pelvic pain * Presence of an extrauterine pelvic mass * Presence of a tubal implant for sterilization * Previous pelvic irradiation * Endometrial cavity length \< 4.5 cm
References
Publications (1)
- DERIVEDShifrin G, Engelhardt M, Gee P, Pschadka G. Transcervical fibroid ablation with the Sonata system for treatment of submucous and large uterine fibroids. Int J Gynaecol Obstet. 2021 Oct;155(1):79-85. doi: 10.1002/ijgo.13638. Epub 2021 Mar 17. PMID 33544889