Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623214
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Assessment of the Safety and Effectiveness of a Micro-RF Skin Treatment Device nebulyft
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessment of the Safety and Effectiveness of a Micro Radiofrequency Skin Treatment Device nebulyft
Status:
COMPLETED
Status Verified Date:
2024-09
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:
ASEMRSTD
Brief Summary:
The objective of the study is to evaluate the safety efficacy and usage compliance of the home-use device nebulyft for self-treatment of wrinkles appearance The participants do treatment 5 time week and last 4 weeks Each treatment takes 16min to complete Photographs will be taken before treatment and 1 month after the completion of treatment to compare the wrinkle scale
Detailed Description:
This is a single-arm prospective study aimed at evaluating the safety and efficacy of nebulyft device treatment of facial areas Nebulyft device is a low-power radio frequency device designed to reduce facial wrinkles 42 subjects will be enrolled in a single clinical site
The included subjects will use the device at specified areas including the cheek for nasolabial fold lines and outer eye corners for crow39s feet lines Each side of the nasolabial fold receives 4 minutes of treatment and each outer eye corner receives 4 minutes of treatment too The total time for each treatment is 16 minutes The study consists of at least five wrinkle reduction treatments a week at home for four consecutive weeks The first treatment session will be conducted under the supervision of the principal investigator PI and the remaining sessions will be conducted at home with remote assistance from the PI when necessary
A Self-selection and Labeling Comprehension study will be conducted that includes three main questions regarding the intended use of the device treatment areas and the possibility of using the device according to the contraindications
A usability study will be conducted as part of the clinical study The study was divided into several steps The PI must observe the test subject to ensure compliance with all the procedures
In the first visit the independent treatment for wrinkle reduction was performed under the investigators observation Patients were asked to rate the pain level and note any problemsdifficulties during the treatments
The subjects perform treatment at home for 4 continuous weeks and return for photography at the end of the treatment They will be asked to rate the pain level of the treatment during the visit
The subjects take final photographs 4 weeks after finishing the treatment and rate the overall satisfaction of the treatment
The included subjects will use the device at specified areas including the cheek for nasolabial fold lines and outer eye corners for crow39s feet lines Each side of the nasolabial fold receives 4 minutes of treatment and each outer eye corner receives 4 minutes of treatment too The total time for each treatment is 16 minutes The study consists of at least five wrinkle reduction treatments a week at home for four consecutive weeks The first treatment session will be conducted under the supervision of the principal investigator PI and the remaining sessions will be conducted at home with remote assistance from the PI when necessary
A Self-selection and Labeling Comprehension study will be conducted that includes three main questions regarding the intended use of the device treatment areas and the possibility of using the device according to the contraindications
A usability study will be conducted as part of the clinical study The study was divided into several steps The PI must observe the test subject to ensure compliance with all the procedures
In the first visit the independent treatment for wrinkle reduction was performed under the investigators observation Patients were asked to rate the pain level and note any problemsdifficulties during the treatments
The subjects perform treatment at home for 4 continuous weeks and return for photography at the end of the treatment They will be asked to rate the pain level of the treatment during the visit
The subjects take final photographs 4 weeks after finishing the treatment and rate the overall satisfaction of the treatment
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