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

Tubal Sterilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00588497
• Other study ID #: 628-04
• Status: Completed
• Phase: N/A
• First received: December 22, 2007
• Last updated: May 20, 2011
• Start date: February 2004
• Est. completion date: March 2006

Study information

• Verified date: May 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Tubal Sterilization

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

External Links

•   Mayo Clinic Clinical Trials