Symphion® System In-Office Study

Completed · Not applicable

Conditions studied: Uterine Leiomyomas, Endometrial Polyps

In brief

The purpose of this study is to determine the safety and feasibility of using the Symphion system in an office setting.

Key facts

Study ID

NCT02520414

Run by

Minerva Surgical, Inc.

People needed

10

Starts

2014-11-01

Expected to finish

2015-04-01

Last updated by the study team

2021-03-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet the approved Instructions for Use for the Symphion® bipolar hysteroscopic tissue resection system
• Confirmation hysteroscopic evaluation to access appropriate pathology type and size meets the Protocol guidelines for inclusion
• Subject has signed written Informed Consent

You may not qualify if…

• Subjects who are pregnant
• Subjects who have an active genital tract infection (as assessed by the physician)
• Subjects who have cervical malignancies
• Subjects who have previously been diagnosed with endometrial cancer
• Subjects who have Type 2 intracavitary myomas
• Type 0 or 1 intracavitary myoma greater than 3.0 cm

Where it is running

• Center for Women's Surgery — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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