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

NCT00588497 | Completed

• 1 other identifier: 628-04
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

female sterilization, micro-insert, hysteroscopy

Study Arms (1)

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.

Procedure: Micro-insert hysteroscopic sterilization; Radiation: Plain abdominal Xray; Procedure: Pelvic Ultrasound; Radiation: Hysterosalpingogram

Interventions

Micro-insert hysteroscopic sterilization PROCEDURE

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

Study Group

Plain abdominal Xray RADIATION

Performed immediately after micro-inserts placement and at 3 months

Study Group

Pelvic Ultrasound PROCEDURE

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

Study Group

Hysterosalpingogram RADIATION

Performed 3 months after micro-inserts placement

Study Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Adult patients requesting sterilization

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Study Officials

• Abimbola O. Famuyide, M.D.

  Mayo Clinic, Rochester, MN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2007
• First Posted: January 8, 2008
• Study Start: February 1, 2004
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: May 23, 2011

Record last verified: 2011-05

Locations

US (1)