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NCT01504308 · ClinicalTrials.gov registry record · Phase 2
Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids
A Phase 2 study, sponsored by Philips Healthcare.
- Terminated
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT01504308: Clinical Trial Phase 2 study, sponsored by Philips Healthcare.
NCT01504308 is a Phase 2 study that was terminated before completion, run by Philips Healthcare. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01504308, a Phase 2 study, was terminated before completion, sponsored by Philips Healthcare.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
The purpose of this clinical study is to determine whether treatment with the Philips Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) system is effective in the treatment symptomatic uterine leiomyomas (uterine fibroids).
Primary Outcome
AIT is scored dichotomously as follows: 0 = Failure. Failure occurs if an AIT for fibroid related symptoms is administered within 12 months of study treatment. 1 = Success. Success occurs if no AIT is administered for fibroid related symptoms within 12 months of study treatment. An AIT is defined as being one of the following: hysterectomy, myomectomy, uterine artery embolization, endometrial ablation and resection, or another MR-HIFU treatment (with the exception of a 're-treatment' as defin
Interventions
- DEVICE Sham treatment
- DEVICE MR-HIFU treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2012-05 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
Why NCT01504308 stopped before completion
NCT01504308 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham treatment is the first listed.
NCT01504308 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01504308 about?
NCT01504308 is a clinical study titled "Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids". The purpose of this clinical study is to determine whether treatment with the Philips Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) system is effective in the treatment symptomatic uterine leiomyomas (uterine fibroids).
What is the current status of trial NCT01504308?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2012-05. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01504308?
The interventions under investigation include: Sham treatment (DEVICE), MR-HIFU treatment (DEVICE).
Who is sponsoring clinical trial NCT01504308?
This trial is sponsored by Philips Healthcare, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01504308's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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