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NCT00588497 · ClinicalTrials.gov registry record
Characterization of the Essure System Tubal Sterilization Using Ultrasound and X-Ray
A clinical trial, sponsored by Mayo Clinic.
- Completed
- Registry status
- 25
- Enrollment target
NCT00588497: Completed study, sponsored by Mayo Clinic.
NCT00588497 is a clinical trial that has completed, run by Mayo Clinic. The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00588497 has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- 25 participants
- Enrollment target
Study Summary
Tubal sterilization is the most prevalent form of contraception in the United States and the world. Currently, approximately half of these are performed with a laparoscope and half through a mini-laparotomy after delivery. Micro-insert hysteroscopic sterilization system received FDA approval for elective sterilization in 2003. Compared to other forms of female sterilization, this procedure is minimally invasive and does not require entering the abdominal cavity. In addition, it is at least as effective in preventing pregnancy as other forms of tubal occlusion. Given the distinct advantages of this method, it could become the preferred method of tubal sterilization for physicians and their patients. Currently, there is no published data concerning the appearance of the micro-inserts system using other imaging modalities that are commonly used in gynecologic practice. As the use of this device becomes more widespread it will be more commonly encountered in radiographic imaging performed as part of routine patient care. The main objective of this study is to provide important descriptive data concerning the ultrasonographic and x-ray appearance of the micro-insert hysteroscopic sterilization device. An additional objective of this study is to identify characteristics on plain film and ultrasound (US) that correlate with tubal occlusion or patency.
Interventions
- PROCEDURE Micro-insert hysteroscopic sterilization
- RADIATION Plain abdominal Xray
- PROCEDURE Pelvic Ultrasound
- RADIATION Hysterosalpingogram
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2004-02 |
| Est. Completion | 2006-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00588497
The ClinicalTrials.gov registry entry for NCT00588497 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Micro-insert hysteroscopic sterilization is the first listed.
NCT00588497 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00588497 about?
NCT00588497 is a clinical study titled "Characterization of the Essure System Tubal Sterilization Using Ultrasound and X-Ray". Tubal sterilization is the most prevalent form of contraception in the United States and the world. Currently, approximately half of these are performed with a laparoscope and half through a mini-laparotomy after delivery. Micro-insert hysteroscopic sterilization system received FDA approval for ele...
What is the current status of trial NCT00588497?
This trial is currently completed. The enrollment target is 25 participants. The study started on 2004-02. Estimated completion is 2006-03.
What interventions are being tested in trial NCT00588497?
The interventions under investigation include: Micro-insert hysteroscopic sterilization (PROCEDURE), Plain abdominal Xray (RADIATION), Pelvic Ultrasound (PROCEDURE), Hysterosalpingogram (RADIATION).
Who is sponsoring clinical trial NCT00588497?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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