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COMPLETEDNANCT02520414

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.

Lead sponsor: Minerva Surgical, Inc.•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Minerva Surgical, Inc.

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.

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 26, 2021Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment10

Start dateNov 2014

Last updatedMar 26, 2021

Condition

Uterine Leiomyomas Endometrial Polyps

Locations shown

Center for Women's Surgery

Albuquerque, New Mexico

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 26, 2021Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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