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The purpose of this study is to develop a recommended local anesthetic protocol and post-treatment pain management regimen, in order to assure patient comfort during office-based treatment with the MyoSure Hysteroscopic Tissue Removal Device. Subject self-reported pain scores (as rated on an 11 point scale) will be compared at multiple time intervals between all treatment groups.
Forty subjects will be enrolled in a randomized, controlled study conducted at four physician offices or day surgery settings. Subjects will be randomized 1:1 to a local anesthetic group (Group #1 or Group #2). Subjects will undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps, type 0 fibroids, or type I fibroids. Subsequent to the procedure, subjects will be randomized 1:1 within the local anesthetic group to a post procedure pain management group (Group A or Group B). Subject self-reported pain scores (as rated on an 11 point scale)will be compared at three time points: Immediately post procedure, prior to discharge from the treatment facility, and at 48 hours post procedure.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phoenix Gynecology Consultants
Interlace Medical, Inc.
Published on BioPortfolio: 2014-08-27T03:19:16-0400
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 pat...
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Inflation of a balloon catheter within the uterine cavity to control UTERINE HEMORRHAGE.
Measurement or recording of contraction activity of the uterine muscle. It is used to determine progress of LABOR, OBSTETRIC and assess status of pregnancy. It is also used in conjunction with FETAL MONITORING to determine fetal response to stress of maternal uterine contractions.
Tumors or cancer of the UTERINE CERVIX.
Pathological processes of the UTERINE CERVIX.
Loss or destruction of the epithelial lining of the UTERINE CERVIX.
Anesthesia is the loss of feeling or sensation in all or part of the body. It may result from damage to nerves or can be induced by an anesthetist (a medical professional) using anesthetics such as thiopental or propofol or sevoflurane during a surgical ...
Neurology - Central Nervous System (CNS)
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