Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT04743635
Status:
COMPLETED
Last Update Posted:
2023-06-06
First Post:
2021-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
CONtrolled Focal Fibrous Band Release Method Study
Sponsor:
Revelle Aesthetics, Inc
Organization:
Study Overview
Official Title:
CONtrolled Focal Fibrous Band Release Method Study
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:
CONFFIRM
Brief Summary:
Study to evaluate the safety and effectiveness of the Avéli medical device to reduce the appearance of cellulite.
Detailed Description:
Multi-center, single-arm clinical study to evaluate the safety and effectiveness of the Avéli device in reducing the appearance of cellulite.
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?:
None
Is an FDA AA801 Violation?: