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To evaluate the safety and effectiveness of the laser treatment for the treatment of spider angiomas.
The purpose of this study is to evaluate the safety and efficacy of the 532 nm KTP laser within the Cutera Excel V system for the treatment of spider angiomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser treatment | Experimental | Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KTP laser | Device | Dual Wavelength Laser Emitting 532 nm Laser Energy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Global Assessment Scale for Improvement of Spider Angioma | Assessment of Baseline vs. 4 weeks post-final treatment for improvement of spider angiomas using the Physician's Global Assessment scale. High scores indicate better outcomes: 0. None
| Four weeks post laser treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly Stankiewicz, MD FAAD | DuPage Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DuPage Medical Group | Naperville | Illinois | 60563 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Laser Treatment | Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s). KTP laser: Dual Wavelength Laser Emitting 532 nm Laser Energy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Laser Treatment | Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s). KTP laser: Dual Wavelength Laser Emitting 532 nm Laser Energy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Physician's Global Assessment Scale for Improvement of Spider Angioma | Assessment of Baseline vs. 4 weeks post-final treatment for improvement of spider angiomas using the Physician's Global Assessment scale. High scores indicate better outcomes: 0. None
| 1 subject was lost to follow up | Posted | Mean | Standard Deviation | score on a scale | Four weeks post laser treatment. |
|
|
4 weeks post final laser treatment
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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 | Laser Treatment | Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s). KTP laser: Dual Wavelength Laser Emitting 532 nm Laser Energy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margot Doucette | Cutera | 415-657-5518 | mdoucette@cutera.com |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 14 |
| 22 |
| Purpura | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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