Clinical trial · Interventional
Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study
Clinical Study to Assess the Safety and Effectiveness of VizAblate(tm) Intrauterine Ultrasound-guided RF Ablation (IUUSgRFA) of Submucosal and Intramural Uterine Fibroids on the Reduction of Pictorial Blood Loss Assessment Scores
NCT00768742CI-TRIAL-00012738FASTwithdrawnN/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): study revised and reinitiated under another protocol
Summary
Brief summary (as posted)
The primary objective of this study is to test the hypothesis that a minimum 75% volume radiofrequency ablation of fibroids associated with menorrhagia results in reduction of menstrual bleeding.
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 Intrauterine Ultrasound-Guided RF Ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC)
- timeFrame
- Baseline, 3 mo, 6 mo, 9 mo, 12 mo
Secondary outcomes (7)
- measure
- Rate of surgical reintervention
- timeFrame
- 12 mo
- measure
- Quality of Life questionnaires
- timeFrame
- Baseline, 3 mo, 6 mo, 9 mo, 12 mo
- measure
- Time required to return to normal daily activity
- timeFrame
- 7-14 days
- measure
- Adverse events
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Pre-menopausal * Regular, consistent menstrual cycles * Serum progesterone \> 6 ng/ml (19 nmol/L) * 2 months history of PBLAC score of 150-500 * Maximum of 4 type I, type II, or intramural fibroids * Patient is at low risk for cervical cancer * Hemoglobin \> 6 g/dl * Not at risk for pregnancy * No desire for future fertility * Willing and able to complete the follow-up requirements outlined in the study design section of the protocol * Willing to sign a consent form Exclusion Criteria: * Subserosal fibroids. * Any fibroid that obstructs access to the endometrial cavity * FSH \> 20 IU/L * Pregnancy * Evidence of disorders of hemostasis * Use of GnRH agonist or depomedroxyprogesterone acetate or other implantable or injectable progestin and/or estrogen * SERMS/SPRMS within the last 6 months * Current use of any IUD or use of Mirena IUS within the last 3 months * Gynecological malignancy or hyperplasia * Known/suspected abdominal/pelvic cancer * Active pelvic infection (e.g., active salpingitis or other pelvic inflammatory disease) * Adenomyosis * Previous surgical or ablative treatment for fibroids or menorrhagia * Previous uterine artery embolization or occlusion * Patient on anti-coagulation therapy * Needing emergency surgery to treat fibroid symptoms * Concomitant intrauterine polyps. * Major medical or psychiatric illness affecting general health or patient's ability to comply with follow-up schedule or provide valid patient self-assessment data * Contraindication to MRI * Allergy to contrast media * Mild renal insufficiency or worse * Known renal disease * Uncontrolled hypertension lasting 2 years or more * Diabetes * Uterine size \> 10 weeks or 10 cm from ectocervix to fundus.
References
Publications (0)
Data not yet available
No reference posted for this study.