Symphion® System In-Office Study

Uterine Leiomyomas Clinical Trial

Official title:

A Pilot Study to Assess the Feasibility of the Symphion® Bipolar Hysteroscopic Tissue Resection System in an Office Environment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02520414
• Other study ID #: U0524
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: April 2015

Study information

• Verified date: March 2021
• Source: Minerva Surgical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Polyps
• Leiomyoma
• Uterine Leiomyomas

Intervention

Device:
• Symphion® Bipolar Hysteroscopic Tissue Resection System

Locations

Country	Name	City	State
United States	Center for Women's Surgery	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Minerva Surgical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks