Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-31 @ 7:34 PM
Study NCT ID:
NCT06557434
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-07
First Post:
2023-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AV-23-001 AVAVA MIRIA Pilot Study
Sponsor:
AVAVA, Inc.
Organization:
Study Overview
Official Title:
AV-23-001 AVAVA MIRIA Pilot Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
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:
This non-significant risk study is intended to demonstrate the use of the MIRIA Skin Treatment System can show improvement in dermatologic conditions currently indicated for treatment with a laser (such as, but not limited to, benign pigmented lesions, benign cutaneous lesions, wrinkles, textural irregularities, or scars). The study is also intended to assist in determination of the optimal laser configuration and treatment parameters that most consistently yield results.
Detailed Description:
This study is intended to allow clinical evaluation of the feasibility of the MIRIA Skin Treatment System, referred to herein as the SR Skin Rejuvenation Laser, for the treatment of dermatologic conditions currently indicated for treatment with a laser (such as, but not limited to, benign pigmented lesions, benign cutaneous lesions, wrinkles, textural irregularities, or scars). This clinical evaluation is being performed under an investigational protocol to formally collect data for the treatment of different dermatologic conditions.
This prospective, non-randomized, controlled study will include subjects with dermatologic conditions that are currently indicated for treatment with a laser who are willing to have sites exposed to the MIRIA Laser and who agree to comply with the study requirements during the follow-up period, a minimum of 3 months and a maximum of 18 months. Some areas with the dermatologic condition may be left as a control for the treated section. Subjects may also be directed to use some topical cream or lotion for up to 1 month prior to the laser procedure or during the duration of the study, according to the Investigator's standard practice.
This prospective, non-randomized, controlled study will include subjects with dermatologic conditions that are currently indicated for treatment with a laser who are willing to have sites exposed to the MIRIA Laser and who agree to comply with the study requirements during the follow-up period, a minimum of 3 months and a maximum of 18 months. Some areas with the dermatologic condition may be left as a control for the treated section. Subjects may also be directed to use some topical cream or lotion for up to 1 month prior to the laser procedure or during the duration of the study, according to the Investigator's standard practice.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: