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| Name | Class |
|---|---|
| Sound Surgical Technologies, LLC. | INDUSTRY |
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Patients with excessive underarm odor and sweating and/or odor are treated with the VASER system to determine the VASER's effectiveness in reducing underarm sweat and odor
Patients with excessive underarm sweat and/or odor are recruited. The effect that excessive underarm sweat and/or odor has on their lifestyle is evaluated. They are surgically treated with the VASER system and followed up for 6 months to evaluate side effects, adverse events and effectiveness. Additional lifestyle evaluations are completed for comparison to pre-surgery answers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | There is only one arm to this study. All patients will receive treatment with the VASER for their axillary hyperhidrosis/bromidrosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VASER | Device | A small incision will be made in the underarm. A VASER probe will be inserted under the skin to break apart fat and sweat glands under the skin. A small hollow tube will be used to draw out the broken-down skin and the incision will be closed with a stitch. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effectiveness of the VASER for treatment of axillary hyperhidrosis using patient self-report assessments | 6 months | |
| To assess the effectiveness of the VASER for the treatment of axillary bromidrosis using patient self report assessment | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess patient's post-operative pain level following VASER using patient self report assessments. | 2 months | |
| To assess patients healing time following VASER treatment of axillary hyperhidrosis | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Commons Aesthetic Plastic Surgery | Palo Alto | California | 94306 | United States |
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| Label | URL |
|---|---|
| Sound VASER System | View source |
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| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| D000089083 | Body Odor |
| ID | Term |
|---|---|
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
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| To establish safe and effective procedural guidelines and surgical endpoints for the treatment of axillary hyperhidrosis using the VASER | 6 months |
| D013568 | Pathological Conditions, Signs and Symptoms |