Spots Global Cancer Trial Database for Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System

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Trial Identification

Brief Title: Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System

Official Title: Interlace Medical Comparative Sedation Study

Study ID: NCT00979342

Conditions

Uterine Fibroids

Polyps

Interventions

Hysteroscopic Morcellator

Study Description

Brief Summary: 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.

Detailed Description: 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.