NCT04807205

Post Market Study Using The Elite IQ Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Cynosure, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open label, single-center clinical study to collect safety and efficacy data on the Elite iQ workstation. The intended use of the Elite iQ device used in this study is for the treatment of hair removal, pseudo folliculitis barbae, and benign vascular and pigmented lesions.

Detailed description

Up to 20 subjects will be enrolled at up to 1 study center. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments on multiple areas of the body such as, but not limited to, the face, legs, and arms. All subjects will be required to return a follow-up visit at 30 - 90 days after the final treatment in each treatment area.

Conditions

• Hair Removal
• Pseudo Folliculitis Barbae
• Benign Vascular Lesion
• Pigmented Lesions

Interventions

Type	Name	Description
DEVICE	RF Non-Invasive Treatment	Self-controlled single-arm group using the Elite IQ device

Timeline

• Start date: 2021-03-26
• Primary completion: 2022-03-02
• Completion: 2022-03-02
• First posted: 2021-03-19
• Last updated: 2024-06-12
• Results posted: 2023-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study