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To evaluate the safety and effectiveness of the Excel V system for the treatment of lower extremity spider veins on the ankles.
The purpose of this study is to evaluate the real-world effectiveness of the 532 nm and 1064 nm Nd:YAG lasers within the Cutera Excel V system for the treatment of lower extremity spider veins, specifically on the ankles, within a clinic setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser treatments | Experimental | Each subject will receive a combination of 532 nm and/or 1064 nm Nd:YAG laser treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nd:YAG laser | Device | Treatment of lower extremity spider veins |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician Global Assessment of Improvement in Treated Spider Veins on the Ankles | Improvement in treated ankle spider veins at 4 weeks post final laser treatment (compared to baseline) as assessed by a blinded evaluators Physician Global Assessment Scale score (Min=0; 4= Max). Higher Score Indicates Better Outcome. | Four weeks post final laser treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction With Improvement in Treated Spider Veins on the Ankles | Subject satisfaction with improvement in spider veins on the ankles as assessed using the Subject Satisfaction Assessment scale (Min=1, Max=5) at 4 weeks post final treatment. Higher score indicates better outcome. | Four weeks post final 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 Treatments | Each subject will receive a combination of 532 nm and/or 1064 nm Nd:YAG laser treatment on lower extremity spider veins. Darker colored veins located deeper in the dermis are likely to be treated with the 1064 nm Nd:YAG laser. Lighter colored, smaller veins located more superficially are likely to be treated with the 532 nm laser. The intent of the study was not to compare the level of treatment (e.g 532 nm vs 1064nm) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Laser Treatments | Each subject will receive a combination of 532 nm \and/or 1064 nm Nd:YAG laser treatment on lower extremity spider veins |
| 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 | Physician Global Assessment of Improvement in Treated Spider Veins on the Ankles | Improvement in treated ankle spider veins at 4 weeks post final laser treatment (compared to baseline) as assessed by a blinded evaluators Physician Global Assessment Scale score (Min=0; 4= Max). Higher Score Indicates Better Outcome. | 1 enrolled participant was lost to follow-up prior to receiving treatment | Posted | Mean | Standard Deviation | score on a scale | Four weeks post final laser treatment. |
|
|
Treatment through 4-weeks post final treatment, up to 6 months
Definition of adverse event and/or serious adverse event, used to collect adverse event information, did not differ from the clinicaltrials.gov.
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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 Treatments | Each subject will receive a combination of 532 nm and/or 1064 nm Nd:YAG laser treatment on lower extremity spider veins. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Stankiewicz, MD FAAD | DuPage Medical Group | (630) 547-5040 | kjstanki@gmail.com |
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| ID | Term |
|---|---|
| D013684 | Telangiectasis |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Subject Satisfaction With Improvement in Treated Spider Veins on the Ankles | Subject satisfaction with improvement in spider veins on the ankles as assessed using the Subject Satisfaction Assessment scale (Min=1, Max=5) at 4 weeks post final treatment. Higher score indicates better outcome. | 1 enrolled participant was lost to follow-up prior to receiving treatment | Posted | Mean | Standard Deviation | score on a scale | Four weeks post final laser treatment |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| Edema | Skin and subcutaneous tissue disorders |
|
| Discomfort | Skin and subcutaneous tissue disorders |
|
| Post Inflammatory Hyperpigmentation | Skin and subcutaneous tissue disorders |
|
| Darkening of Vessel | Skin and subcutaneous tissue disorders |
|
| Purpura | Skin and subcutaneous tissue disorders |
|
| Crusting | Skin and subcutaneous tissue disorders |
|
| Nodule | Skin and subcutaneous tissue disorders |
|
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