Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-01 @ 9:41 PM
Study NCT ID:
NCT02873104
Status:
COMPLETED
Last Update Posted:
2018-02-28
First Post:
2016-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pivotal Study of the truSculpt Radiofrequency Device for Circumferential Reduction
Sponsor:
Cutera Inc.
Organization:
Study Overview
Official Title:
Pivotal Study of the truSculpt Radiofrequency Device for Circumferential Reduction
Status:
COMPLETED
Status Verified Date:
2017-02
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:
To evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for circumferential reduction.
Detailed Description:
The objectives of this study are to evaluate efficacy and safety of treatment with the Cutera truSculpt RF device for circumferential reduction in the abdominal and flank region.
Study Oversight
Has Oversight DMC:
False
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?: