Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-30 @ 7:55 AM
Study NCT ID:
NCT06283056
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2023-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RF Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite
Sponsor:
InMode MD Ltd.
Organization:
Study Overview
Official Title:
Radiofrequency Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite
Status:
COMPLETED
Status Verified Date:
2025-06
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:
The aim of the study is to evaluate the safety and efficacy of Morpheus 8 Body 40-pin tip up to 7mm depth Applicator for subdermal treatment of cellulite appearance, skin laxity, and subcutaneous fat deposits.
Detailed Description:
The aim of the study is to evaluate the safety and efficacy of Morpheus 8 Body 40-pin tip up to 7mm depth Applicator for subdermal treatment of cellulite appearance, skin laxity, and subcutaneous fat deposits.
Prospective, open-label, baseline-controlled, clinical study to evaluate the Morpheus8 device for treatment of cellulite, skin laxity, and subcutaneous fat deposits of the thighs.
Eligible subjects will undergo two treatments with the Morpheus8 device using the 3, 5 7 mm depths or sequential (Burst) mode, based on the treating physician's discretion.
Prospective, open-label, baseline-controlled, clinical study to evaluate the Morpheus8 device for treatment of cellulite, skin laxity, and subcutaneous fat deposits of the thighs.
Eligible subjects will undergo two treatments with the Morpheus8 device using the 3, 5 7 mm depths or sequential (Burst) mode, based on the treating physician's discretion.
Study Oversight
Has Oversight DMC:
False
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?: