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Clinical Trial Summary

This is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow.


Clinical Trial Description

This is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow. Up to 112 healthy candidates who are seeking treatment from participating investigators will be enrolled at up to 5 participating study sites. Patients will receive 2 treatments (4-6 weeks ± 2 weeks apart) with the SofWave system and will be followed up to 3 months post the last treatment (FU2). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04146584
Study type Interventional
Source Sofwave Medical LTD
Contact
Status Completed
Phase Phase 2
Start date November 20, 2019
Completion date March 30, 2021

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