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HOME Study: Hysteroscopic Office Myomectomy Evaluation

2014-07-24 14:00:52 | BioPortfolio

Summary

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.

Description

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.

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 (The MyoSure Tissue Removal Device)

Location

Women's Health Research
Phoenix
Arizona
United States
85015

Status

Recruiting

Source

Interlace Medical, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:00:52-0400

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Medical and Biotech [MESH] Definitions

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.

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