Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-02-28 @ 12:03 AM
Study NCT ID:
NCT04406935
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2020-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and Efficacy of the NuEra Tight for Abdominal Circumference Reduction
Sponsor:
Lumenis Be Ltd.
Organization:
Study Overview
Official Title:
Evaluation of the Safety and Efficacy of the NuEra Tight for Abdominal Circumference Reduction
Status:
COMPLETED
Status Verified Date:
2020-02
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:
Clinical study to evaluate the safety and efficacy of the NuEra Tight for circumferential reduction in the abdominal region within three treatment group
Detailed Description:
The study design to evaluate the safety and efficacy of the NuEra Tight for circumferential reduction in the abdominal region within three treatment group. each group has a different radio-frequency. The study hypothesis is that NuEra Tight is safe and will cause a reduction in abdominal circumferential after treatment and at 12 week post last treatment within each treatment group.
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?: