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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00588497 |
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.
Condition | Intervention |
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Tubal Sterilization |
Procedure: Micro-insert hysteroscopic sterilization Radiation: Plain abdominal Xray Procedure: Pelvic Ultrasound Radiation: Hysterosalpingogram |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Characterization of the Essure System Tubal Sterilization Using Ultrasound and X-Ray |
Enrollment: | 25 |
Study Start Date: | February 2004 |
Study Completion Date: | March 2006 |
Groups/Cohorts | Assigned Interventions |
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Study Group
Twenty-five subjects for this study will be recruited from patients who have requested a form of permanent sterilization, and who, after considering all the options, choose the trans-cervical hysteroscopic sterilization for this end. Any subject who is deemed suitable for the micro-insert hysteroscopic sterilization system (Essure micro-insert system, Conceptus Incorporated, Mountain View, California) placement will be offered the opportunity to participate in the study.
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Procedure: Micro-insert hysteroscopic sterilization
Placement of micro-inserts transcervically with the aid of a hysteroscope
Radiation: Plain abdominal Xray
Performed immediately after micro-inserts placement and at 3 months
Procedure: Pelvic Ultrasound
Performed immediately after micro-inserts placement and at 3 months.
Radiation: Hysterosalpingogram
Performed 3 months after micro-inserts placement
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Twenty-five subjects for this study will be recruited from patients who have requested a form of permanent sterilization, and who, after considering all the options, choose the trans-cervical hysteroscopic sterilization for this end. Any subject who is deemed suitable for the micro-insert hysteroscopic sterilization system (Essure micro-insert system, Conceptus Incorporated, Mountain View, California) placement will be offered the opportunity to participate in the study. Consent will be documented on a Mayo Clinic patient consent form at the time the decision is made to schedule the procedure.
Inclusion Criteria:
Exclusion Criteria:
These include hypersensitivity to nickel-titanium or contrast media, current or recent pregnancy (within the previous six weeks), active genital tract infection, prior tubal ligation, or known congenital uterine malformation.
Responsible Party: | Chair, Division of Gynecology, Mayo Clinic, Rochester, MN ( Abimbola O. Famuyide, M.D. ) |
Study ID Numbers: | 628-04 |
Study First Received: | December 22, 2007 |
Last Updated: | December 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00588497 History of Changes |
Health Authority: | United States: Institutional Review Board |
female sterilization, micro-insert, hysteroscopy |