Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06282172
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2024-02-12
Brief Title:
Histological Evaluation of BTL-785F Devices Effect on Submental Subcutaneous Adipose Tissue
Sponsor:
BTL Industries Ltd
Organization:
BTL Industries Ltd
Study Overview
Official Title:
Effect of Treatment With BTL-785F Device on Submental Subcutaneous Adipose Tissue - Histological Evaluation
Status:
COMPLETED
Status Verified Date:
2024-02
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:
This study aims to evaluate the safety and effectiveness of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of subcutaneous submental fat
Detailed Description:
This study aims to evaluate the safety and effectiveness of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of subcutaneous submental fat The changes in the fat tissue related to the morphology shape size and count will be assessed histologically The presence of biochemical apoptotic indicators will be analysed in the adipocytes
The study is a prospective single-center open-label two-arm study The subjects will be enrolled and assigned into two study groups Group A which will receive active treatment 5 subjects and Group B 2 subjects will serve as the control and will not receive any treatment to verify the treatment outcomes
Subjects will be required to complete one 1 treatment visit and three 3 follow-up visits at 24 hours 7 days and 14 days post treatment The third follow-up visit is for safety evaluation
At baseline inclusion and exclusion criteria will be verified upon obtaining informed consent from the patient
Punch biopsies 3mm diameter will be obtained from the treatment area for histologic analysis In the control group biopsy will be obtained from the location corresponding to the treatment area in the active group
Safety measures will include documentation of adverse events AE during and after the treatment procedures and at the follow up visits and if needed medical assistance
The study is a prospective single-center open-label two-arm study The subjects will be enrolled and assigned into two study groups Group A which will receive active treatment 5 subjects and Group B 2 subjects will serve as the control and will not receive any treatment to verify the treatment outcomes
Subjects will be required to complete one 1 treatment visit and three 3 follow-up visits at 24 hours 7 days and 14 days post treatment The third follow-up visit is for safety evaluation
At baseline inclusion and exclusion criteria will be verified upon obtaining informed consent from the patient
Punch biopsies 3mm diameter will be obtained from the treatment area for histologic analysis In the control group biopsy will be obtained from the location corresponding to the treatment area in the active group
Safety measures will include documentation of adverse events AE during and after the treatment procedures and at the follow up visits and if needed medical assistance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None