Symphion® System In-Office Study

Minerva Surgical

Status: Completed

Conditions: Uterine Leiomyomas; Endometrial Polyps

Treatments: Device: Symphion® Bipolar Hysteroscopic Tissue Resection System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02520414

U0524

Details and patient eligibility

About

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

Full description

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.

Enrollment: 10 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Symphion®

Experimental group

Description:

Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.

Treatment:

Device: Symphion® Bipolar Hysteroscopic Tissue Resection System