A Hysteroscopic Office Myomectomy Evaluation Using the MyoSure Tissue Removal System for the Removal of Uterine Fibroids and Polyps in the Treatment of Abnormal Uterine Bleeding (AUB)
Approximately one hundred subjects will be enrolled in a randomized, comparative setting
study conducted at 10-15 investigational sites. Sixty subjects will be randomized to undergo
treatment in an office setting, and 40 subjects will be randomized to undergo treatment in a
hospital or ambulatory surgical center (ASC) setting. Subjects will undergo a hysteroscopic
tissue removal procedure to remove intrauterine polyps, type 0 fibroids, or type I fibroids.
Saline infused sonohysterogram images (SIS) obtained at three months post treatment will be
compared to pre-treatment images, to determine the percent reduction in target pathology
volume. Additionally, subject self-reported pain scores (as rated on an 11 point scale) will
compare pain occurring during the treatment procedure to the average pain level experienced
during a PAP smear. Economic data will be collected and compared between the two treatment
settings.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percent reduction in target pathology volume
Percent reduction in target pathology volume, compared between pre-treatment baseline and month 3 post MyoSure treatment assessments, as measured by saline infused sonohysterogram.
Three months post treatment
No
Edward Evantash, MD
Study Director
Sponsor GmbH
United States: Institutional Review Board
TMP 2009003
NCT01152112
June 2010
March 2013
Name | Location |
---|---|
Complete Healthcare for Women | Columbus, Ohio 43231 |
Phoenix Gynecology Consultants | Phoenix, Arizona 85013 |
Boulder Women's Clinic | Boulder, Colorado 80303 |
Women's Health Care Practice | Champaign, Illinois 61820 |
The Research Division for Integrated Health Services | Ann Arbor, Michigan 48106 |
Rubino OB/Gyn | West Orange, New Jersey 07052 |
Obstetrics and Gynecology | North Charleston, North Carolina 29406 |
Williams, Benavides, Marston, & Kaminski | Raleigh, North Carolina 27609 |
Kulbresh Women's Center | Irmo, South Carolina 29063 |