Abstract
The primary objective of this study is to evaluate the performance of the IOGYN System in removing abnormal uterine pathologies including submucosal myomas and endometrial polyps. Secondary objectives involve: Assessing the performance of the Fluid Management System; tissue characterization including histopathology; and other system and procedure performance characteristics. A Multi-Center, International, Single-Arm, Feasibility Clinical Study. Five investigational centers in Mexico and Hungary. A total of up to 50 Women diagnosed with submucous fibroids and/or endometrial polyps. IOGYN Procedure. The primary safety evaluation is the occurrence of adverse events. Primary effectiveness evaluation is performed by assessing the adequacy of removal of abnormal uterine pathologies including submucosal myomas and endometrial polyps. Secondary objectives involve: Assessing the performance of the Fluid Management System; tissue characterization including histopathology; and other system and procedure performance characteristics. Most up to date clinical results from this in-progress study will be reported. This multi-center, international, feasibility clinical study will be the first to generate information regarding the performance of the IOGYN System in removing benign uterine pathology.
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