Back to resultsSymphion® System In-Office Study
Primary Purpose
Uterine Leiomyomas, Endometrial Polyps
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Symphion® Bipolar Hysteroscopic Tissue Resection System
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Leiomyomas
Eligibility 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
Sites / Locations
- Center for Women's Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Symphion®
Arm Description
Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02520414
First Posted
November 6, 2014
Last Updated
March 24, 2021
Sponsor
Minerva Surgical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02520414
Brief Title
Symphion® System In-Office Study
Official Title
A Pilot Study to Assess the Feasibility of the Symphion® Bipolar Hysteroscopic Tissue Resection System in an Office Environment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minerva Surgical, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the safety and feasibility of using the Symphion system in an office setting.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Leiomyomas, Endometrial Polyps
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Symphion®
Arm Type
Experimental
Arm Description
Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.
Intervention Type
Device
Intervention Name(s)
Symphion® Bipolar Hysteroscopic Tissue Resection System
Primary Outcome Measure Information:
Title
Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas.
Description
Absence of device related adverse events, or death.
Time Frame
2 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Center for Women's Surgery
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
12. IPD Sharing Statement
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Symphion® System In-Office Study
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