Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565988
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 Voluma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Post-market-clinical Follow-up Investigation of Safety and Performance of Decoria Voluma
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-VOL
Brief Summary:
A post-market-clinical follow-up investigation of safety and performance of Decoria Voluma by the correction of midface volume deficit by tissue augmentation in cheek region
Detailed Description:
This will be a post-market open-label prospective interventional confirmatory evaluator-blinded multi- centre clinical investigation to confirm the clinical safety and performance profile of Decoria Voluma for the correction of midface volume deficit by tissue augmentation in cheek region
Subjects desiring correction of cheek volume at the participating sites will be asked to participate in the clinical investigation According to the 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 6 months with follow-up and assessments either by physical visits to a clinic Visit 2 and Visit 4 or by phone call Visit 3
A total of 4 visits including screening Visit 0 at the site are planned for each subject
Standardized facial photography will be taken prior to and after treatment during Visit 1 and during each follow-up visit at the clinic Visit 2 and 4 for evaluation according to GAIS grading and for the exploratory instrumental evaluation of cheek volume GAIS will be used for blinded investigator 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 cheek volume at the participating sites will be asked to participate in the clinical investigation According to the 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 6 months with follow-up and assessments either by physical visits to a clinic Visit 2 and Visit 4 or by phone call Visit 3
A total of 4 visits including screening Visit 0 at the site are planned for each subject
Standardized facial photography will be taken prior to and after treatment during Visit 1 and during each follow-up visit at the clinic Visit 2 and 4 for evaluation according to GAIS grading and for the exploratory instrumental evaluation of cheek volume GAIS will be used for blinded investigator 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