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The purpose of this study is to demonstrate safety and effectiveness of the MyoSure Tissue Removal System when used by community gynecologists in an office setting for the treatment of patients with symptomatic intrauterine polyps and submucosal fibroids.
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Hysteroscopic Morcellator (The MyoSure Tissue Removal Device)
Women's Health Research
Interlace Medical, Inc.
Published on BioPortfolio: 2014-07-24T14:00:52-0400
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Removal of an implanted therapeutic or prosthetic device.
Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.
Removal of a MEDICAL DEVICE from the market due to a problem occurring in the manufacture or distribution of the product.
Surgical removal of a LEIOMYOMA of the UTERUS.
Contraceptive devices placed high in the uterine fundus with a string extending from the device through the cervical as into the vagina. (UMDNS, 1999)
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