Ignite Creation Date:
2024-05-06 @ 5:39 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05388617
Status:
TERMINATED
Last Update Posted:
2023-11-29
First Post:
2022-05-19
Brief Title:
Study To Assess Radiofrequency Diathermocontraction Device For Muscle Stimulation And The Treatment Of Abdominal Fat
Sponsor:
Cynosure Inc
Organization:
Cynosure Inc
Study Overview
Official Title:
Prospective Clinical Study To Assess The Safety And Efficacy Of A Radiofrequency Diathermocontraction Device For Muscle Stimulation And The Treatment Of Abdominal Fat
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study stopped because of a business decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The intended use of the device in this study to assess the safety and efficacy of the adhesive electrodes for muscle stimulation and the treatment of abdominal fat on the abdomen andor flanks
Detailed Description:
Subjects are to be enrolled in this clinical study if they are a healthy male or female 18 years of age or older Up to 30 subjects will be enrolled at 1 study center Subjects will be enrolled into 2 groups Group A and Group B Subjects will be enrolled in Group A if they present with abdominal fat and are able to be present for all visits as outlined in Schedule of Visits and Procedures - Group A Subjects will enroll in Group B for training and experience purposes only and will follow the visit schedule as outlined in Schedule of Visits and Procedures - Group B
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