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A Two-Phase Clinical Study of the Minerva AURORA Ablation System

2015-04-18 12:23:22 | BioPortfolio

Summary

The primary objective of this study is to evaluate the use of the Aurora Ablation System in reducing menstrual blood loss at 12 months post-treatment. The occurrence of adverse events will be assessed along with an assessment of the reduction of uterine bleeding as measured by a pictorial blood loss assessment chart (PBLAC) or menstrual diary.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Menorrhagia Due to Benign Causes

Intervention

Aurora Endometrial Ablation System

Location

University of Szeged
Szeged
Csongrad
Hungary
6725

Status

Completed

Source

Minerva Surgical, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-04-18T12:23:22-0400

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Medical and Biotech [MESH] Definitions

Neoplasms of the endometrial stroma that sometimes involve the MYOMETRIUM. These tumors contain cells that may closely or remotely resemble the normal stromal cells. Endometrial stromal neoplasms are divided into three categories: (1) benign stromal nodules; (2) low-grade stromal sarcoma, or endolymphatic stromal myosis; and (3) malignant endometrial stromal sarcoma (SARCOMA, ENDOMETRIAL STROMAL).

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