Characterization of the Essure System Tubal Sterilization Using Ultrasound and X-Ray
May 20, 2011 updated by: Mayo Clinic
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55902
- Mayo Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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Placement of micro-inserts transcervically with the aid of a hysteroscope
Performed immediately after micro-inserts placement and at 3 months
Performed immediately after micro-inserts placement and at 3 months.
Performed 3 months after micro-inserts placement
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Abimbola O. Famuyide, M.D., Mayo Clinic, Rochester, MN
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Primary Completion (Actual)
March 1, 2006
Study Completion (Actual)
March 1, 2006
Study Registration Dates
First Submitted
December 22, 2007
First Submitted That Met QC Criteria
December 22, 2007
First Posted (Estimate)
January 8, 2008
Study Record Updates
Last Update Posted (Estimate)
May 23, 2011
Last Update Submitted That Met QC Criteria
May 20, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- 628-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.