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Clinical Trial Summary

Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation.


Clinical Trial Description

Eligible patients will receive 1-2 face and/or neck and/or submental treatments (per PI discretion, 2-12 weeks apart) using the SofWave system with the Lift or/and Precise applicators. Treatment may be administered after the enrollment and screening at the first visit, or it may occur at a later date following the enrollment and screening activities based on site scheduling availabilities. All patients will return to the clinic for one follow-up visit at 3 months ± 2 weeks post last treatment (FU1). Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06333067
Study type Interventional
Source Sofwave Medical LTD
Contact Shlomit Mann, MSc
Phone +972-4-7800268
Email Shlomit@sofwave.com
Status Recruiting
Phase N/A
Start date October 11, 2023
Completion date November 1, 2024

See also
  Status Clinical Trial Phase
Completed NCT04146467 - Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region N/A
Completed NCT05358327 - Treatment for Lifting Upper Arm Lax Skin N/A
Completed NCT03487172 - Sculptra Aesthetic for the Treatment of Upper Knee Skin Laxity N/A