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NCT00147108 · ClinicalTrials.gov registry record · Phase 3
MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas
A Phase 3 study, sponsored by InSightec.
- Terminated
- Registry status
- Phase 3
- Development phase
- 102
- Enrollment target
NCT00147108 is a Phase 3 study that was terminated before completion, run by InSightec. The registered enrollment target is 102 participants.
The verdict
NCT00147108, a Phase 3 study, was terminated before completion, sponsored by InSightec.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 102 participants
- Enrollment target
Study Summary
The primary objective of this pivotal study is to evaluate the safety and efficacy of FUS treatment of breast fibroadenomas. Our hypothesis is that FUS lesion ablation of a fibroadenoma will have the following results: a. lead to a decrease in lesion cross-sectional area of \> 50% on palpation, and \>65% in lesion volume as measured by MRI (both calculations assume an elliptical shape of the lesion in all 3 dimensions). b. this decrease in size, along with the softening of the treated volume will result in satisfactory clinical results in greater than 50 % of the patients.
Interventions
- DEVICE ExAblate 2000
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2003-01 |
| Est. Completion | 2005-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00147108
The ClinicalTrials.gov registry entry for NCT00147108 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is InSightec, which has 38 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ExAblate 2000 is the first listed.
NCT00147108 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00147108 about?
NCT00147108 is a clinical study titled "MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas". The primary objective of this pivotal study is to evaluate the safety and efficacy of FUS treatment of breast fibroadenomas. Our hypothesis is that FUS lesion ablation of a fibroadenoma will have the following results: a. lead to a decrease in lesion cross-sectional area of \> 50% on palpation, and ...
What is the current status of trial NCT00147108?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 102 participants. The study started on 2003-01. Estimated completion is 2005-10.
What interventions are being tested in trial NCT00147108?
The interventions under investigation include: ExAblate 2000 (DEVICE).
Who is sponsoring clinical trial NCT00147108?
This trial is sponsored by InSightec, which has 38 total clinical trials registered on ClinicalTrials.gov.
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