Abstract
To demonstrate the safety and effectiveness of SureSound for determination of cervical and cavity lengths prior to endometrial ablation with NovaSure. Prospective trial utilizing a self assessment test. Multi-Center office and hospital venues. Adult women with dysfunctional uterine bleeding deemed suitable for cervical dilation procedures. A work-up with history and physical exam, appropriate lab and ultrasound was performed to insure suitable candidates for surgical procedures. Cervical Dilation was performed by utilizing the SureSound Device and traditional methods. Utilizing self-assessment forms, physicians compared SureSound and traditional methods on several parameters: detection of external os and the maintenance of position of the device; evaluation of the uterine fundus for both normal and tilted uteri; safety and lack of trauma to the anatomy; and disengagement and overall satisfaction. Preliminary data of 30 evaluation forms have been analyzed. The SureSound features worked well, with a majority of physicians strongly agreeing on the benefits of the SureSound Device. When compared to the individual evaluator’s current method, the majority showed SureSound to be overall superior in all parameters. The physician rating of the SureSound devise was found to be overall superior.
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