MyoSure Hysteroscopic Tissue Removal System Registry Study
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Procedure Efficacy
Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatmet procedure
1 hour post treatment
No
Edward Evantash
Principal Investigator
Hologic, Inc.
United States: Institutional Review Board
TMP 200905
NCT01369758
November 2010
November 2013
Name | Location |
---|---|
Hologic, Inc. | Marlborough, Massachusetts 01752 |