Clinical trial · Interventional
Fibroid Ablation Study - Large Fibroids
Symptom Effectiveness Study of VizAblate® Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Large Uterine Fibroids
NCT01539187CI-TRIAL-00017142FAST-LterminatedN/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
Summary
Brief summary (as posted)
The purpose of this study is to establish the effectiveness and confirm the safety of the VizAblate System in the ablation of large (\> 5 cm) 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 intervention
- description
- VizAblate System with subject serving as her own control
- interventionNames
- Device: VizAblate System
Primary outcomes (1)
- measure
- Mean percentage change in target fibroid perfused volume
- timeFrame
- Baseline, 3 months, 12 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 * Consistent menstrual cycles * History of excessive bleeding for at least 3 months * Baseline UFS-QOL Symptom severity score ≥ 20 * At least one target fibroid having a maximum diameter \> 5cm and ≤ 10 cm * Not at material risk for pregnancy * Willingness to participate, adhere to follow-up requirements, and sign the informed consent form * Willing to have uniform maintenance of antifibrinolytic or non steroidal anti-inflammatory agents * Menstrual Pictogram score ≥ 120 during a one-month screening period. Exclusion Criteria: * Presence of type 0 intracavitary fibroids * Target fibroid \> 10cm in maximum diameter * Abnormality of the endometrial cavity that obstructs access of the treatment device * Postmenopausal * Desire for current or future fertility * Hemoglobin \< 6 g/dl * Evidence of disorders of hemostasis * Use of GnRH agonist or depomedroxyprogesterone acetate or other implantable or injectable progestin and/or estrogen, SERM or SPRM within the last 6 months prior to screening * Evidence for current cervical dysplasia (CIN II or greater) * Endometrial hyperplasia * Confirmed abdominal / pelvic malignancy within previous five years * Active pelvic infection or positive screen for pelvic gonorrhea or chlamydia * Clinically significant adenomyosis * Previous uterine artery embolization * Previous surgical or ablative treatment for fibroids or menorrhagia within 12 months prior to screening * Current use of anticoagulant therapy * Major medical or psychiatric illness affecting general health or ability to adhere to follow-up * Contraindication to MRI * Renal insufficiency * Uncontrolled hypertension lasting 2 years or more * Calcified fibroids * Presence of extrauterine pelvic mass * Presence of tubal implant for sterilization * Previous pelvic irradiation * Endometrial cavity length \< 4.5 cm
References
Publications (0)
Data not yet available
No reference posted for this study.