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The purpose of this study is to determine the safety and feasibility of using the Symphion system in an office setting.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symphion® | Experimental | Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symphion® Bipolar Hysteroscopic Tissue Resection System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Women's Surgery | Albuquerque | New Mexico | 87106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Symphion® | Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System. Symphion® Bipolar Hysteroscopic Tissue Resection System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Symphion® | Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System. Symphion® Bipolar Hysteroscopic Tissue Resection System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of participants | 2 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Symphion® | Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System. Symphion® Bipolar Hysteroscopic Tissue Resection System |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meaghan Wilk Clinical Project Manager | Boston Scientific | 5086834113 | meaghan.wilk@bsci.com |
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| ID | Term |
|---|---|
| D047708 | Myofibroma |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |