NCT04153071

Unipolar Microplasma Radiofrequency Device: In-vivo Histologic Study

Evaluation of the Cutaneous Effects of a Unipolar Microplasma Electrode Pin Radiofrequency Device: An In-vivo Histologic Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Alma Lasers · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Skin Resurfacing

Interventions

Type	Name	Description
DEVICE	OPUS system	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.

Timeline

• Start date: 2019-10-23
• Primary completion: 2020-09-16
• Completion: 2020-09-16
• First posted: 2019-11-06
• Last updated: 2020-09-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study