Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-01-01 @ 8:53 AM
Study NCT ID:
NCT05398159
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2022-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trim II for Noninvasive Lipolysis and Circumference Reduction of Abdomen.
Sponsor:
InMode MD Ltd.
Organization:
Study Overview
Official Title:
Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference Reduction of Abdomen
Status:
COMPLETED
Status Verified Date:
2024-06
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:
At least 90 female and male subjects, from 6 investigational sites, aged 18-70 seeking non-invasive lipolysis and circumference reduction of abdomen will be enrolled. Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol.Study duration for each subject is approximately 6 months (including screening, 3 treatments and 2 follow-up visits at 1 and 3 months post last treatment).
Detailed Description:
The goal of this prospective study is to evaluate Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference Reduction of Abdomen.
The main questions are :
* Efficacy of the Trim II treatment for lipolysis and abdominal circumference reduction.
* Safety of the Trim II treatment for lipolysis and abdominal circumference reduction
Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol.
The main questions are :
* Efficacy of the Trim II treatment for lipolysis and abdominal circumference reduction.
* Safety of the Trim II treatment for lipolysis and abdominal circumference reduction
Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol.
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?: