Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562075
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
A Post-market-clinical Follow-up Investigation of Safety and Performance by Decoria Intense Strong
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Post-market-clinical Follow-up Investigation of Safety and Performance by Decoria Intense Strong
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
DAG-ISJ
Brief Summary:
A post-market Follow up clinical investigation to confirm the clinical safety and performance profile of DecoriaIntense Strong for the correction and improvement of jawline profile
Detailed Description:
This will be a post-market open label prospective interventional confirmatory evaluator-blindedmulti - centre clinical investigation to confirm the clinical safety and performance profile of DecoriaIntense Strong for the correction and improvement of jawline profile
Subjects desiring correction of their jawline profile at the participating sites will be asked to participate in the clinical investigation According to national legislation all subjects must have a consultation with the respective clinic and receive both oral and written information at least 48 hours prior to treatment with fillers as to allow for sufficient reflection time
If the subject decides to participate the subject will receive treatment on Day 0 Visit 1 At 1 month visit Visit 2 an optional touch-up may be given as well as assessments performed All subjects will be followed for 9 months with follow-up and assessments by visits Visit 2 Visit 3 and Visit 5 and phone call Visit 4
Standardized facial photography will be taken prior to and after treatment during Visit 1 and 2 and during each follow-up visit at the clinic Visit 3 and Visit 5 for evaluation according to GAIS and the exploratory instrumental evaluation of jawline contour GAIS will be used for blinded-evaluator assessment treating Investigator assessment and patient satisfaction
Numeric Pain Rating Scale NRS at each visit involving an injection Visit 1 and Visit 2 - optional touch up will be used to measure pain
Subjects desiring correction of their jawline profile at the participating sites will be asked to participate in the clinical investigation According to national legislation all subjects must have a consultation with the respective clinic and receive both oral and written information at least 48 hours prior to treatment with fillers as to allow for sufficient reflection time
If the subject decides to participate the subject will receive treatment on Day 0 Visit 1 At 1 month visit Visit 2 an optional touch-up may be given as well as assessments performed All subjects will be followed for 9 months with follow-up and assessments by visits Visit 2 Visit 3 and Visit 5 and phone call Visit 4
Standardized facial photography will be taken prior to and after treatment during Visit 1 and 2 and during each follow-up visit at the clinic Visit 3 and Visit 5 for evaluation according to GAIS and the exploratory instrumental evaluation of jawline contour GAIS will be used for blinded-evaluator assessment treating Investigator assessment and patient satisfaction
Numeric Pain Rating Scale NRS at each visit involving an injection Visit 1 and Visit 2 - optional touch up will be used to measure pain
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