NCT05091788

Robotic Mechanical Coring for the Treatment of Moderate to Severe Facial Wrinkles

Clinical Evaluation of the Safety and Efficacy of Aime Robotic Mechanical Coring Device for the Treatment of Moderate to Severe Facial Wrinkles

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Venus Concept · Industry
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study is a prospective, up to 4 center study of the safety and efficacy of mechanical coring with skin closure of cored holes, intended for the improvement in the appearance of wrinkles of the cheeks in up to 70 subjects after two treatments.

Detailed description

Prospective, up to 4 center study of the safety and efficacy of mechanical coring with Tegaderm tape skin closure of cored holes to achieve improvement in the appearance of wrinkles of the cheeks. The study will evaluate the progress of up to 70 subjects after two treatments on the cheeks. Up to 70 subjects who meet inclusion/exclusion criteria will be treated. All subjects will be monitored for a period 7, 37, 60 and 120 days post treatment.

Conditions

• Wrinkle

Interventions

Type	Name	Description
DEVICE	Venus Aime	Venus Aime is a micro-coring device of the skin that can potentially help reduce moderate to severe facial wrinkles.

Timeline

• Start date: 2022-03-22
• Primary completion: 2025-08-15
• Completion: 2025-08-15
• First posted: 2021-10-25
• Last updated: 2024-01-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study