Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT01665118
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2012-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Trusculpt (Radio Frequency) Device For Thigh Circumference Reduction
Sponsor:
Cutera Inc.
Organization:
Study Overview
Official Title:
The Cutera Trusculpt Device For Thigh Circumference Reduction
Status:
COMPLETED
Status Verified Date:
2023-01
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 objective of this study is to evaluate the safety and efficacy of the Trusculpt (Radio Frequency) device in the reduction of thigh circumference.
Detailed Description:
The primary efficacy variable for this study is the comparison of mean change in thigh circumference from baseline to 12 weeks between two arms. The primary research hypothesis is that the mean change in thigh circumference is ≥ 1 cm (indicating mean reduction).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: