Spots Global Cancer Trial Database for MyoSure Hysteroscopic Tissue Removal System Registry Study
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Trial Identification
Brief Title: MyoSure Hysteroscopic Tissue Removal System Registry Study
Official Title: MyoSure Hysteroscopic Tissue Removal System Registry Study
Study ID: NCT01369758
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Hologic, Inc., Marlborough, Massachusetts, United States
Contact Details
Name: Edward Evantash
Affiliation: Hologic, Inc.
Role: PRINCIPAL_INVESTIGATOR
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