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

NCT00588497 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2011-05-23

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Abimbola O. Famuyide, M.D. · Mayo Clinic, Rochester, MN

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2006-03-31
Completion
2006-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00588497 on ClinicalTrials.gov