Symphion® System In-Office Study

A Pilot Study to Assess the Feasibility of the Symphion® Bipolar Hysteroscopic Tissue Resection System in an Office Environment

The purpose of this study is to determine the safety and feasibility of using the Symphion system in an office setting.

The purpose is to determine the safety and feasibility of using an intrauterine tissue resection system in the office setting, as well as to expand the national discussion regarding in-office hysteroscopic procedures as it relates to the highest standards of care and cost containment.

Inclusion Criteria:

• Subjects must meet the approved Instructions for Use for the Symphion® bipolar hysteroscopic tissue resection system
• Confirmation hysteroscopic evaluation to access appropriate pathology type and size meets the Protocol guidelines for inclusion
• Subject has signed written Informed Consent

Exclusion Criteria:

• Subjects who are pregnant
• Subjects who have an active genital tract infection (as assessed by the physician)
• Subjects who have cervical malignancies
• Subjects who have previously been diagnosed with endometrial cancer
• Subjects who have Type 2 intracavitary myomas
• Type 0 or 1 intracavitary myoma greater than 3.0 cm