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Completed

NCT Number: NCT02520414

Symphion® System In-Office Study

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

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Key information

Conditions

Uterine Leiomyomas Connective Tissue Diseases Endometrial Polyps Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Women's Surgery

Albuquerque, New Mexico, 87106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Symphion® Bipolar Hysteroscopic Tissue Resection System

Device

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Minerva Surgical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 11, 2015
Registry last updated
Mar 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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