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Comparative Sedation Study of the MyoSure Hysteroscopic Tissue Removal System

2014-08-27 03:19:16 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Uterine Fibroids

Intervention

Hysteroscopic Morcellator

Location

Phoenix Gynecology Consultants
Phoenix
Arizona
United States
85013

Status

Recruiting

Source

Interlace Medical, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:16-0400

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