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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-02-29

Study Completion Date

2006-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Tubal Sterilization

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Micro-insert hysteroscopic sterilization

Intervention Type PROCEDURE

Placement of micro-inserts transcervically with the aid of a hysteroscope

Plain abdominal Xray

Intervention Type RADIATION

Performed immediately after micro-inserts placement and at 3 months

Pelvic Ultrasound

Intervention Type PROCEDURE

Performed immediately after micro-inserts placement and at 3 months.

Hysterosalpingogram

Intervention Type RADIATION

Performed 3 months after micro-inserts placement

Interventions

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Micro-insert hysteroscopic sterilization

Placement of micro-inserts transcervically with the aid of a hysteroscope

Intervention Type PROCEDURE

Plain abdominal Xray

Performed immediately after micro-inserts placement and at 3 months

Intervention Type RADIATION

Pelvic Ultrasound

Performed immediately after micro-inserts placement and at 3 months.

Intervention Type PROCEDURE

Hysterosalpingogram

Performed 3 months after micro-inserts placement

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No