Symphion® System In-Office Study

• Sponsor: Minerva Surgical, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02520414
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Leiomyomas; Endometrial Polyps	Device: Symphion® Bipolar Hysteroscopic Tissue Resection System	N/A

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

• Study Type: Interventional
• 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: Nov 1, 2014
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

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

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. [2 weeks]

   Absence of device related adverse events, or death.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Women's Surgery	Albuquerque	New Mexico	United States	87106

Sponsors and Collaborators

• Minerva Surgical, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Minerva Surgical, Inc.
• ClinicalTrials.gov Identifier: NCT02520414
• Other Study ID Numbers: U0524
• First Posted: Aug 11, 2015
• Last Update Posted: Mar 26, 2021
• Last Verified: Mar 1, 2021

• Additional relevant MeSH terms: Leiomyoma; Myofibroma

Study Results

Participant Flow

Arm/Group Title	Symphion®
Arm/Group Description	Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System. Symphion® Bipolar Hysteroscopic Tissue Resection System
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Symphion®
Arm/Group Description	Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System. Symphion® Bipolar Hysteroscopic Tissue Resection System
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.4 (5.7)
Sex: Female, Male (Count of Participants)
Female	10 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 50%
Not Hispanic or Latino	5 50%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	29.6 (7.2)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Symphion®
Arm/Group Description	Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System. Symphion® Bipolar Hysteroscopic Tissue Resection System
Measure Participants	10
Adverse Events	0 0%
Device Malfunctions	0 0%

Adverse Events

Arm/Group Title	Symphion®
Arm/Group Description	Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System. Symphion® Bipolar Hysteroscopic Tissue Resection System
All Cause Mortality
	Symphion®
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Symphion®
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Symphion®
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.