Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454994
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-06
Brief Title:
Clinical Study to Evaluate Safety and Effectiveness of Noble Lift Lifting Threads
Sponsor:
GCS Co Ltd
Organization:
GCS Co Ltd
Study Overview
Official Title:
A Prospective Multicentric Comparative Split-face Clinical Study to Evaluate Safety and Effectiveness of Noble Lift Lifting Threads
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
The aim of this study is to compare two models of the Nobel Lift range PDO sutures with similar PDO devices available on the market in a split-face comparative study Each thread model will be used in one indication upper face eyebrow lift or mid-face and lower-face
Aesthetic efficacy of the devices will be evaluated and compared with the Global Aesthetic Improvement Scale GAIS jowl laxity scale subjective evaluation of the patient and photographs during a 12-months period Safety of the devices and procedures will also be evaluated
Aesthetic efficacy of the devices will be evaluated and compared with the Global Aesthetic Improvement Scale GAIS jowl laxity scale subjective evaluation of the patient and photographs during a 12-months period Safety of the devices and procedures will also be evaluated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None