Clinical trial NCT00588497: Characterization of the Essure System Tubal Sterilization Using Ultrasound and X-Ray
Official title: Characterization of the Essure System Tubal Sterilization Using Ultrasound and X-Ray
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tubal Sterilization
Keywords: female sterilization, micro-insert, hysteroscopy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-08
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic, Rochester, MN
name: Abimbola O. Famuyide, M.D.
role: PRINCIPAL_INVESTIGATOR
References: