Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT05182502
Status:
UNKNOWN
Last Update Posted:
2022-04-06
First Post:
2021-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Photodamage at Low Settings
Sponsor:
Eric Bernstein, MD
Organization:
Study Overview
Official Title:
A Prospective, Single-center, Single-arm Clinical Study Evaluating the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Photodamage at Low Settings
Status:
UNKNOWN
Status Verified Date:
2022-04
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:
To demonstrate the safety and performance of the Tixel fractional system for treatment of photodamage using low-energy settings.
Detailed Description:
A Prospective, single-center, single-arm clinical study of subjects who are seeking a procedure to reduce the appearance of photodamage, and meet study eligibility criteria, and have provided informed consent will be enrolled in the study. One investigational center will participate in the recruitment. Each study subject will receive 3 treatments with Tixel at 4-6 week intervals. Final follow-up will occur 3 months following the last treatment
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?:
False
Is an FDA AA801 Violation?: