Symphion® System In-Office Study

Not Applicable

Completed

• Conditions: Endometrial Polyps; Uterine Leiomyomas
• Interventions: Device: Symphion® Bipolar Hysteroscopic Tissue Resection System

• Registration Number: NCT02520414
• Lead Sponsor: Minerva Surgical, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-06
• Primary Completion: 2015-03
• Study Completion: 2015-04
• Study First Submitted QC: 2015-08-10
• Study First Posted: 2015-08-11
• Results First Submitted: 2017-03-23
• Results First Submitted QC: 2017-05-05
• Results First Posted: 2017-06-07
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas.	2 weeks	Absence of device related adverse events, or death.

Trial Locations

Locations (1)

Center for Women's Surgery; 🇺🇸 Albuquerque, New Mexico, United States