Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT06333067
Brief Summary:
Open-label, non-randomized single-arm prospective, multi-center, self-controlled clinical study with masked evaluation.
Detailed 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:
NCT06333067
Study Brief:
Protocol Section:
NCT06333067