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NCT00837161 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of MRI-Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
A Phase 1 study, sponsored by Philips Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT00837161 is a Phase 1 study that has completed, run by Philips Healthcare. The registered enrollment target is 11 participants.
The verdict
NCT00837161, a Phase 1 study, has completed, sponsored by Philips Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
Uterine fibroids (leiomyomas) are a common cause of heavy uterine bleeding and pain in reproductive aged women and are the most common cause of hysterectomy in the United States. Women are seeking new ways to treat symptomatic uterine fibroids that allow them to avoid surgery. This study is the first step in this quest. We will study the novel use of magnetic resonance imaging (MRI) in enhancing the safety of the FDA approved technique to treat fibroids called High Intensity Focused Ultrasound (HIFU). The term 'high intensity focused ultrasound' means using ultrasound to heat and to thermally destroy tissue, in this case, uterine fibroids. The MRI system will allow us to watch the ultrasound path during treatment and monitor the temperature increase in the fibroid tissue that comes during the procedure. In this pilot study, women with symptomatic fibroids will undergo MRI guided HIFU and then have a hysterectomy. This will allow us to confirm studies done in animals which show that it is possible to destroy specific tissue without harming normal tissue surrounding the targeted area. The purpose of this clinical study is to confirm the safety and treatment capabilities of the Philips MR guided HIFU system for ablation of uterine fibroids. This is a single arm pilot study of 10 women who will undergo hysterectomy after the HIFU procedure. This study design of hysterectomy after treatment has been requested by the FDA as part of IDE approval for this new device and mirrors what has been required for similar devices. Safety will be assessed by evaluating treatment accuracy, complications, and adverse events. Treatment capabilities will be assessed by evaluating the fibroid volume ablated and other factors related to the procedure feasibility and acceptance including procedure duration, time to return to normal activity, and pain scores at the time of the procedure. Study population The Philips MR-HIFU System is intended for ablation of uterine fibroid tissue in pre-
Interventions
- DEVICE Philips MR guided HIFU system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2009-01 |
| Est. Completion | 2010-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00837161
The ClinicalTrials.gov registry entry for NCT00837161 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Philips Healthcare, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Philips MR guided HIFU system is the first listed.
NCT00837161 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00837161 about?
NCT00837161 is a clinical study titled "Pilot Study of MRI-Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids". Uterine fibroids (leiomyomas) are a common cause of heavy uterine bleeding and pain in reproductive aged women and are the most common cause of hysterectomy in the United States. Women are seeking new ways to treat symptomatic uterine fibroids that allow them to avoid surgery. This study is the firs...
What is the current status of trial NCT00837161?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2009-01. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00837161?
The interventions under investigation include: Philips MR guided HIFU system (DEVICE).
Who is sponsoring clinical trial NCT00837161?
This trial is sponsored by Philips Healthcare, which has 10 total clinical trials registered on ClinicalTrials.gov.
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