Study Objective: To assess the safety and placement effectiveness of a new delivery catheter for the Essure micro-insert hysteroscopic sterilization system.
Design: Prospective, multicenter, single-arm clinical study. (Canadian Task Force classification II-3).
Setting: Hospital-based clinical research centers.
Patients: One hundred two women of reproductive age and proven fertility.
Intervention: A new coil catheter delivery system was used for micro-insert placement.
Measurements And Main Results: The bilateral placement of micro-inserts using the coil catheter delivery system occurred in 100 women out of 102 attempts (98%). The two women who did not have successful micro-insert placement were subsequently shown to have proximal tubal stenotic disease.
Conclusion: These findings indicate that the introduction of the coil catheter delivery system for Essure hysteroscopic sterilization improves the micro-insert bilateral placement rate when compared with previous studies. It is hypothesized that the coil catheter has superior navigational properties, particularly within tortuous or narrowed tubal lumens.
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| http://dx.doi.org/10.1016/s1074-3804(05)60056-4 | DOI Listing |
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