Clinical Trial
Clinical Trial, Phase II
Journal Article
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Ultrasound: an effective method for localization of the echogenic Essure sterilization micro-insert: correlation with radiologic evaluations.

STUDY OBJECTIVE: To examine the reliability and practicality of performing office-based transvaginal ultrasound for determining the ease of locating the Essure hysteroscopic sterilization micro-insert and compare its usefulness against established radiologic evaluations.

DESIGN: Prospective single-center, single-arm, clinical study (Canadian Task Force classification xx).

SETTING: Hospital-based clinical research center.

PATIENTS: One hundred forty-five women of reproductive age and proven fertility.

INTERVENTION: Thirty-seven women who underwent the Essure hysteroscopic method of sterilization had routine radiologic and transvaginal ultrasound assessments for determining the retention of these micro-inserts from 3 months to 2 years after placement. An additional 108 women had ultrasound assessment as the only means of micro-insert localization 3 months after placement.

MEASUREMENTS AND MAIN RESULTS: The 145 women (100%) who underwent an ultrasound assessment at a 3-month, posthysteroscopic-sterilization office visit had their micro-inserts readily identified and localized to the uterotubal area due to the micro-inserts' dense echogenic properties. For the 37 women who had both assessments, the ultrasound findings correlated with pelvic radiograph and hysterosalpingogram assessments of micro-insert location in all instances. In addition, the ultrasound evaluations provided additional information about the micro-inserts relative position to the surrounding, less-echogenic soft tissue structures of the upper uterotubal area. In the 37 women who had serial ultrasound and radiologic evaluations performed for up to 2 years after micro-insert placement, ultrasound was found to be equally effective in identifying the location of the micro-inserts and indicted that their position remained identifiable and stable over time.

CONCLUSION: A single transvaginal ultrasound in-office examination, performed 3 months after hysteroscopic micro-insert placement, was found to be a simple, reliable, and convenient method of assessing micro-insert location, when compared with radiologic assessments.

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