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Per Investigator and sponsor decision
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Prospective, Open-Label, Single-Center Pilot Study.
The study is aimed to evaluate the histologic effects of a unipolar microplasma electrode pin radiofrequency device (Alma Lasers OPUS system) on the abdominal skin.
The study will include up to 2 subjects. Each subject will have a single cutaneous treatment of their lower abdomen, with variable treatment parameters. Punch biopsies will be obtained from each treatment section, for in-vivo histological evaluations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unipolar microplasma RF treatment | Experimental | Single cutaneous unipolar microplasma RF treatment, with variable treatment parameters |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPUS system | Device | Each subject will have a single cutaneous treatment of their lower abdomen, with variable treatment parameters. Punch biopsies will be obtained from each treatment section, for in-vivo histological evaluations. |
| Measure | Description | Time Frame |
|---|---|---|
| Diameter and depth of ablation and/or coagulation from varying RF device treatment parameters | Histology analysis to evaluate the diameter and depth of ablation and/or coagulation from varying microplasma RF device treatment parameters, based on biopsy specimens | Immediately post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adverse events | Safety will be monitored by documentation of adverse events | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Friedmann, MD, FAAD | Westlake Dermatology Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westlake Dermatology Clinical Research Center | Austin | Texas | 78746 | United States |
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