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NCT00730886 · ClinicalTrials.gov registry record · NA
ExAblate Treatment of Uterine Fibroids for Fertility Enhancement
A NA study, sponsored by InSightec.
- Terminated
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT00730886 is a NA study that was terminated before completion, run by InSightec. The registered enrollment target is 2 participants.
The verdict
NCT00730886, a NA study, was terminated before completion, sponsored by InSightec.
- TERMINATED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study Summary
The objective of this trial is to evaluate the efficacy and safety of the ExAblate 2000 system for enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids, who are diagnosed with unexplained infertility. Uterine fibroids are fairly common in women of child-bearing age. An evidence based review supported removing fibroids that distort the uterine cavity to increase pregnancy rates and decrease the rates of miscarriage. Some fibroids can be removed hysteroscopically which is minimally invasive, with low morbidity. However, removal of fibroids within the uterine wall require more invasive surgical procedures (e.g., myomectomy), with increasing morbidity risks including, but not limited to, infection, blood loss and postoperative uterine adhesions. ExAblate is approved by FDA for the treatment of uterine fibroids; however, its use in patients seeking pregnancy is considered experimental. Accumulated evidence suggests there are no significant complications from the procedure in women seeking pregnancy as with existing fibroid therapies; however, these data are based on a small number of patients. This study will evaluate fertility enhancement following ExAblate treatment or myomectomy, in women with unexplained infertility and who have non-hysteroscopically resectable uterine fibroids.
Interventions
- DEVICE ExAblate 2000
- PROCEDURE Myomectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2008-07 |
| Est. Completion | 2011-10-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00730886
The ClinicalTrials.gov registry entry for NCT00730886 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 2 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 2 interventions - of which ExAblate 2000 is the first listed.
NCT00730886 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00730886 about?
NCT00730886 is a clinical study titled "ExAblate Treatment of Uterine Fibroids for Fertility Enhancement". The objective of this trial is to evaluate the efficacy and safety of the ExAblate 2000 system for enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids, who are diagnosed with unexplained infertility. Uterine fibroids are fairly common in women of child-bearing a...
What is the current status of trial NCT00730886?
This trial is currently terminated. It is a NA study. The enrollment target is 2 participants. The study started on 2008-07. Estimated completion is 2011-10-06.
What interventions are being tested in trial NCT00730886?
The interventions under investigation include: ExAblate 2000 (DEVICE), Myomectomy (PROCEDURE).
Who is sponsoring clinical trial NCT00730886?
This trial is sponsored by InSightec, which has 38 total clinical trials registered on ClinicalTrials.gov.
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