Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04569253
Status:
COMPLETED
Last Update Posted:
2022-06-14
First Post:
2020-08-27
Brief Title:
Multi-Center Pivotal Study of Radiofrequency Device
Sponsor:
Cynosure Inc
Organization:
Cynosure Inc
Study Overview
Official Title:
Clinical Study to Assess the Safety and Efficacy of the Tempsure Firm for Non-invasive Lipolysis of the Flanks
Status:
COMPLETED
Status Verified Date:
2022-06
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:
This is a prospective controlled multi-center study Patients will be enrolled and treated with a radiofrequency device in this study if they have unwanted fat in the flank love handle area
Detailed Description:
Subjects are to be enrolled in this clinical study if they are 18 - 55 years old A maximum of 55 subjects will be enrolled at up to 6 study centers Subjects will receive up to 5 treatments with the TempSure Firm on one flank The other flank will be left untreated to serve a control Subject will be required to return for follow-up visits at 6 weeks and at 12 weeks after the subjects final treatment All subjects will receive a phone call 1 week 1-10 days post each treatment
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?:
True
Is an FDA AA801 Violation?:
None