Characterization of the Essure System Tubal Sterilization Using Ultrasound and X-Ray

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588497
First received: December 22, 2007
Last updated: May 20, 2011
Last verified: May 2011

December 22, 2007
May 20, 2011
February 2004
March 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00588497 on ClinicalTrials.gov Archive Site
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Characterization of the Essure System Tubal Sterilization Using Ultrasound and X-Ray
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 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.

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Observational
Time Perspective: Prospective
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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.

Tubal Sterilization
  • 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
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.
Interventions:
  • Procedure: Micro-insert hysteroscopic sterilization
  • Radiation: Plain abdominal Xray
  • Procedure: Pelvic Ultrasound
  • Radiation: Hysterosalpingogram
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
March 2006
March 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients requesting sterilization

Exclusion Criteria:

  • Unsuccessful placement of the hysteroscopic sterilization system in one or both fallopian tubes. In addition, a patient will not be offered the opportunity to participate in the study if there are any conditions that would preclude attempted placement of the hysteroscopic sterilization system. 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.
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00588497
628-04
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Abimbola O. Famuyide, M.D., Chair, Division of Gynecology, Mayo Clinic, Rochester, MN
Mayo Clinic
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Principal Investigator: Abimbola O. Famuyide, M.D. Mayo Clinic, Rochester, MN
Mayo Clinic
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP