Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-01-28 @ 7:21 PM
Study NCT ID:
NCT02489994
Status:
UNKNOWN
Last Update Posted:
2016-03-18
First Post:
2015-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance of the ePrime System for Cellulite
Sponsor:
Syneron Medical
Organization:
Study Overview
Official Title:
Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of Cellulite
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Performance of the ePrime System for the Treatment of Cellulite.
Detailed Description:
Up to 60 healthy adult volunteers seeking cellulite treatment, females of 25 to 60 years of age, from multiple investigational sites.
This is an open-label, multi-center study. Subjects in this study will receive a single subcutaneous treatment with the ePrime device in one treatment session according to the study protocol.
Prior to treatments, tissue to be treated will be injected with tumescence or local dermal infiltration solution according to the protocol. Subjects will return for follow-up (FU) visits at: 1 week, 1 month, 3 months and 6 months following the treatment.
Methodology described in protocol to evaluate efficacy of treatments will be carried out at each visit.
This is an open-label, multi-center study. Subjects in this study will receive a single subcutaneous treatment with the ePrime device in one treatment session according to the study protocol.
Prior to treatments, tissue to be treated will be injected with tumescence or local dermal infiltration solution according to the protocol. Subjects will return for follow-up (FU) visits at: 1 week, 1 month, 3 months and 6 months following the treatment.
Methodology described in protocol to evaluate efficacy of treatments will be carried out at each visit.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: