Endometrial Polyps, Uterine Leiomyomas
Conditions
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.
Interventions
DEVICESymphion® Bipolar Hysteroscopic Tissue Resection System
Sponsors
Minerva Surgical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Symphion® Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.
Symphion® Bipolar Hysteroscopic Tissue Resection System | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Symphion® |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 50.4 years STANDARD_DEVIATION 5.7 |
| Body Mass Index | 29.6 kg/m^2 STANDARD_DEVIATION 7.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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.
Time frame: 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Symphion® | Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas. | Adverse Events | 0 percentage of participants |
| Symphion® | Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas. | Device Malfunctions | 0 percentage of participants |