NCT02520414

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 11, 2015

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

June 7, 2017

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

November 6, 2014

Results QC Date

March 23, 2017

Last Update Submit

March 24, 2021

Conditions

Uterine LeiomyomasEndometrial Polyps

Outcome Measures

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.

    Absence of device related adverse events, or death.

    2 weeks

Study Arms (1)

Symphion®

EXPERIMENTAL

Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.

Device: Symphion® Bipolar Hysteroscopic Tissue Resection System

Interventions

Symphion® Bipolar Hysteroscopic Tissue Resection SystemDEVICE
Symphion®

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must meet the approved Instructions for Use for the Symphion® bipolar hysteroscopic tissue resection system
  • Subject has signed written Informed Consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Women's Surgery

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Meaghan Wilk Clinical Project Manager
Organization
Boston Scientific
meaghan.wilk@bsci.com
5086834113

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2014

First Posted

August 11, 2015

Study Start

November 1, 2014

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

March 26, 2021

Results First Posted

June 7, 2017

Record last verified: 2021-03

Locations

US(1)