Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333067
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-20
Brief Title:
Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators
Sponsor:
Sofwave Medical LTD
Organization:
Sofwave Medical LTD
Study Overview
Official Title:
Safety and Efficacy of SofWave Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor neck andor submental treatments per PI discretion 2-12 weeks apart using the SofWave system with the Lift orand 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None