NCT04910945

Mechanical Coring to Achieve Directional Skin Tightening

Pilot Study for the Clinical Evaluation of Mechanical Coring to Achieve Directional Skin Tightening

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Venus Concept · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The objective of this clinical study is to evaluate the safety and efficacy of mechanical coring for directional skin tightening. This study is a prospective, up to 3 center, multiple skin treatment area study of the safety and efficacy of mechanical coring with directional closure to achieve directional skin tightening.

Detailed description

The study will evaluate the progress of up to 70 subjects after one treatment at up to 6 treatment areas on the body chosen from 2 on the neck (each treatment area approximately 1x3 cm), 2 on each underarm, 1 on each cheek, 2 on the abdomen, one on each thigh and 2 on the forehead area above the eyebrows (all approximately 6x4 cm). Subjects will be followed at 2, 5, 14, 28, 60, and 90 days after treatment.

Conditions

• Skin Tightening
• Healthy Volunteers

Interventions

Type	Name	Description
DEVICE	VENUS AIME (RoboCor)	VENUS AIME is a micro-coring device of the skin that can potentially help to reduce visible skin scarring, improve skin laxity and reduce wrinkles.

Timeline

• Start date: 2021-02-14
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2021-06-02
• Last updated: 2024-02-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study