NCT00588497

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tubal Sterilization

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-02-01
• Primary completion: 2006-03-01
• Completion: 2006-03-01
• First posted: 2008-01-08
• Last updated: 2011-05-23

Locations

1 site across 1 country: United States