Symphion® System In-Office Study

N/ACompletedNCT02520414

Minerva Surgical, Inc.10 enrolled

Overview

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

The purpose is to determine the safety and feasibility of using an intrauterine tissue resection system in the office setting, as well as to expand the national discussion regarding in-office hysteroscopic procedures as it relates to the highest standards of care and cost containment.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Uterine Leiomyomas Endometrial Polyps

Interventions

Symphion® Bipolar Hysteroscopic Tissue Resection SystemDEVICE

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Center for Women's Surgery

Albuquerque, New Mexico, United States

Outcomes

Primary Outcomes

Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas.

Absence of device related adverse events, or death.

Time frame: 2 weeks

Data from ClinicalTrials.gov

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