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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588497
First received: December 22, 2007
Last updated: May 20, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention
Tubal Sterilization
 Procedure: Micro-insert hysteroscopic sterilization
Radiation: Plain abdominal Xray
Procedure: Pelvic Ultrasound
Radiation: Hysterosalpingogram

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Characterization of the Essure System Tubal Sterilization Using Ultrasound and X-Ray

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Enrollment: 25
Study Start Date: February 2004
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588497

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Abimbola O. Famuyide, M.D. Mayo Clinic, Rochester, MN
  More Information

Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Abimbola O. Famuyide, M.D., Chair, Division of Gynecology, Mayo Clinic, Rochester, MN
ClinicalTrials.gov Identifier: NCT00588497     History of Changes
Other Study ID Numbers: 628-04
Study First Received: December 22, 2007
Last Updated: May 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
female sterilization, micro-insert, hysteroscopy

Additional relevant MeSH terms:
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013