Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-01-06 @ 9:42 AM
Study NCT ID:
NCT03270150
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2017-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen
Sponsor:
BTL Industries Ltd.
Organization:
Study Overview
Official Title:
Evaluation of Safety and Efficacy of the BTL-899 Device for Non-invasive Lipolysis and Circumference Reduction of Abdomen
Status:
COMPLETED
Status Verified Date:
2023-04
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 study is a prospective open-label single-arm study that includes three treatment procedures and four follow-up visits.
Detailed Description:
This study will evaluate the clinical efficacy and safety of the BTL-899 device for non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will complete three (3) treatment visits and will be invited to four (4) follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is the optional one.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: