NCT06457607

Evaluating the Efficacy and Safety of Treatment With LinearFirm(ULTRAcel Q+) in Temporary Eyebrow Lifting

Prospective, Single Center, Single Arm, Open Label Study to Evaluate the Efficacy and Safety of Treatment With LinearFirm(ULTRAcel Q+) in Temporary Eyebrow Lifting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Jeisys Medical Inc · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

Prospective, single center, single arm, open label study to evaluate the efficacy and safety of treatment with LinearFirm(ULTRAcel Q+) in temporary eyebrow lifting

Detailed description

The goal of this open label study is to evaluate the efficacy and safety of treatment with HIFU system (LinearFirm(ULTRAcel Q+)) in temporary eyebrow lifting. The target number of subjects for this clinical trial is set to 30 in a single group, without considering the statistical significance of hypothesis testing and dropout rate. Considering a dropout rate of 20%, the plan is to recruit a total of 38 subjects. 1. Evaluation of the effacacy is includes: Evaluation of eyebrow lifting photos by an independent evaluator, Patient Satisfaction (PS) 2. Evaluation of the safety is includes: Adverse events, vital signs, physical examination, and Visual Analogue Scale (VAS) after the application of medical devices for clinical trials

Conditions

• High Intensity Focused Ultrasound

Interventions

Type	Name	Description
DEVICE	LinearZ	High Intensity Focues Ultrasound

Timeline

• Start date: 2023-02-24
• Primary completion: 2023-09-27
• Completion: 2023-09-27
• First posted: 2024-06-13
• Last updated: 2024-06-13

Locations

1 site across 1 country: South Korea