Wrinkle Clinical Trial - Lutronic Genius System for Neck Treatment

Status Completed

Clinical Trial Summary

The Genius system is substantially equivalent to the Infini device (K121481). The study is a prospective, multi-site, non-randomized study of up to 30 treated subjects presenting for treatment of mild to moderate lines, wrinkles, textural concerns, and/or skin laxity of the neck.

Clinical Trial Description

At enrollment, standardized baseline/pretreatment 2D and 3D images will be obtained from each subject. Study subjects will receive three neck treatments completed 30 days apart. Subjects will be contacted via a phone call 3 days following each treatment to assess for adverse events and expected treatment effects. Effectiveness assessments will occur prior to Treatments #2 and #3, and a follow-up visit will be completed at 90 days following Treatment #3. Each assessment visit will include efficacy, adverse events, and expected treatment effects assessments, and post-treatment 2D and 3D digital images will be captured. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03534609
Study type	Interventional
Source	LUTRONIC Corporation
Contact
Status	Completed
Phase	N/A
Start date	March 27, 2018
Completion date	January 10, 2020

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