Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457607
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2024-06-02
Brief Title:
Evaluating the Efficacy and Safety of Treatment With LinearFirmULTRAcel Q in Temporary Eyebrow Lifting
Sponsor:
Jeisys Medical Inc
Organization:
Jeisys Medical Inc
Study Overview
Official Title:
Prospective Single Center Single Arm Open Label Study to Evaluate the Efficacy and Safety of Treatment With LinearFirmULTRAcel Q in Temporary Eyebrow Lifting
Status:
COMPLETED
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:
Prospective single center single arm open label study to evaluate the efficacy and safety of treatment with LinearFirmULTRAcel Q in temporary eyebrow lifting
Detailed Description:
The goal of this open label study is to evaluate the efficacy and safety of treatment with HIFU system LinearFirmULTRAcel Q in temporary eyebrow lifting
The target number of subjects for this clinical trial is set to 30 in a single group without considering the statistical significance of hypothesis testing and dropout rate Considering a dropout rate of 20 the plan is to recruit a total of 38 subjects
1 Evaluation of the effacacy is includes Evaluation of eyebrow lifting photos by an independent evaluator Patient Satisfaction PS
2 Evaluation of the safety is includes Adverse events vital signs physical examination and Visual Analogue Scale VAS after the application of medical devices for clinical trials
The target number of subjects for this clinical trial is set to 30 in a single group without considering the statistical significance of hypothesis testing and dropout rate Considering a dropout rate of 20 the plan is to recruit a total of 38 subjects
1 Evaluation of the effacacy is includes Evaluation of eyebrow lifting photos by an independent evaluator Patient Satisfaction PS
2 Evaluation of the safety is includes Adverse events vital signs physical examination and Visual Analogue Scale VAS after the application of medical devices for clinical trials
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