MyoSure Hysteroscopic Tissue Removal System Registry Study

Not Applicable

Completed

Brief Summary: The objective of this study is to demonstrate the safety and effectiveness of community gynecologist initiated treatment of intra-uterine polyps and submucosal fibroids with the MyoSure Hysteroscopic Tissue Removal System in a significantly sized patient population.

Detailed Description: Between 500 and 600 subjects will be enrolled in a prospective, multi-center registry study. Approximately 100 of these cases will be completed in an office setting, with the remaining 400-500 cases completed in a hospital outpatient or ambulatory surgery center. Subjects will undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps and submucosal fibroids.

Recruitment & Eligibility

Inclusion Criteria

Healthy female between 18 and 65 years of age
Subject must be able to understand, read and sign the study specific informed consent forms after the nature of the study has been fully explained to her
Subject is indicated for myomectomy or polypectomy
Subject exhibits intrauterine polyps and/or submucous myomas which meet one of the following criteria. In cases of subjects with multiple intrauterine pathology, classification is based as follows:
- All polyps
- All Type 0, Type 1 or Type 2 myomas ≤ 6 cm in diameter
- Polyps plus Type 0, Type 1 or Type 2 myomas ≤6 cm in diameter

Exclusion Criteria

Subject is pregnant
Subject has an Intrauterine Device (IUD) at the time of the procedure. A subject may be enrolled in the study if the IUD is removed prior to the treatment procedure
Subject is taking an anticoagulant or antiplatelet medication other than low dose aspirin
Active pelvic inflammatory disease or pelvic/vaginal infection
Subject has a known or suspected coagulopathy or bleeding disorder
Subject has a history of disease which increases the risk for fluid overload (i.e. significant cardiac, hepatic, or renal dysfunction)
Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study

Arm && Interventions

Group	Intervention	Description
Intrauterine pathology, myomectomy	MyoSure Tissue Removal System	Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.

Primary Outcome Measures

Name	Time	Method
Procedure Efficacy	1 hour post treatment	Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatment procedure

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects That Achieve 100% Removal of Target Pathology	1 hour post treatment	Percentage of subjects that achieve 100% removal of target pathology, as determined by hysteroscopic exam following the treatment procedures.