Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT02445495
Status:
COMPLETED
Last Update Posted:
2015-05-15
First Post:
2015-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chart Review of the Efficacy of the GenesisPlus 1064 nm Nd:YAG Laser in the Treatment of Onychomycosis
Sponsor:
Jason K Rivers, MD, FRCPC, FAAD
Organization:
Study Overview
Official Title:
A Single Centre Retrospective Chart Review Study to Assess the Efficacy of the GenesisPlus 1064 nm Nd:YAG Laser in the Treatment of Onychomycosis
Status:
COMPLETED
Status Verified Date:
2015-04
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 purpose of this study is to determine if toenail onychomycosis can be reduced by means of exposure to laser energy from the Cutera® GenesisPlus 1064 Nd:YAG laser system.
Detailed Description:
This is a retrospective, open-label, single-centre study for the collection of clinical data on the efficacy and safety of the Cutera® GenesisPlus 1064 nm Nd:YAG laser for the treatment of nail fungus (onychomycosis). Safety and efficacy of treatment with the GenesisPlus laser will be evaluated by (1) assessment of subject's great toenail photographs at baseline and after two treatments with GenesisPlus Laser utilizing planimetry measurement of infected vs. clear nail area in target toenail photographs, (2) by clinical and subjective review of acute and follow up adverse events that may have resulted from laser treatment of the target toenails.
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?: