Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640998
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Safety and Efficacy of Matrix Pro for Eyebrow Lift and Lift of SubmentalNeck Laxity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Study to Evaluate the Safety and Efficacy of Matrix Pro Applicator Treatment to Lift the Eyebrow and Lift Lax Tissue in the Submentum and Neck
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective non-randomized multi-center pivotal clinical trial
Detailed Description:
This is a two-arm study Eligible participants will receive up to three treatments with the Matrix Pro Applicator for lifting the eyebrow andor improving lax tissue in the submental and neck areas Treatments will be spaced approximately 6 weeks apart 2 weeks and all participants will undergo follow-up evaluations at 1 month 2 weeks and 3 months 2 weeks after the final treatment
Each investigational site will treat two areas In arm 1 the upper face including the forehead and peri-orbital area to lift the eyebrows In arm 2 the lower face including the submental and neck areas to lift lax tissue Each patient could be assigned to both arms Treatment may occur immediately after the screening and enrollment visit or at a later date depending on site scheduling Additional follow-up visits may be required at the investigators discretion
Each investigational site will treat two areas In arm 1 the upper face including the forehead and peri-orbital area to lift the eyebrows In arm 2 the lower face including the submental and neck areas to lift lax tissue Each patient could be assigned to both arms Treatment may occur immediately after the screening and enrollment visit or at a later date depending on site scheduling Additional follow-up visits may be required at the investigators discretion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None