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Symphion® System In-Office Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02520414
Recruitment Status : Completed
First Posted : August 11, 2015
Results First Posted : June 7, 2017
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
Minerva Surgical, Inc.

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

Condition or disease Intervention/treatment Phase
Uterine Leiomyomas Endometrial Polyps Device: Symphion® Bipolar Hysteroscopic Tissue Resection System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Assess the Feasibility of the Symphion® Bipolar Hysteroscopic Tissue Resection System in an Office Environment
Study Start Date : November 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: Symphion®
Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.
 Device: Symphion® Bipolar Hysteroscopic Tissue Resection System


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02520414


Locations
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United States, New Mexico
Center for Women's Surgery
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
Minerva Surgical, Inc.
More Information
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Responsible Party: Minerva Surgical, Inc.
ClinicalTrials.gov Identifier: NCT02520414    
Other Study ID Numbers: U0524
First Posted: August 11, 2015    Key Record Dates
Results First Posted: June 7, 2017
Last Update Posted: March 26, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases