Symphion® System In-Office Study

March 24, 2021 updated by: Minerva Surgical, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Center for Women's Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Symphion®
Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.
Device: Symphion® Bipolar Hysteroscopic Tissue Resection System

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minerva Surgical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

November 6, 2014

First Submitted That Met QC Criteria

August 10, 2015

First Posted (Estimate)

August 11, 2015

Study Record Updates

Last Update Posted (Actual)

March 26, 2021

Last Update Submitted That Met QC Criteria

March 24, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U0524

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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