NCT06557434

AV-23-001 AVAVA MIRIA Pilot Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: AVAVA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Wrinkle
• Acne Scars - Mixed Atrophic and Hypertrophic
• Pigmented Lesions
• Skin Laxity
• Scars

Interventions

Type	Name	Description
DEVICE	MIRIA	The MIRIA Skin Treatment System is a 1550nm-based laser system indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

Timeline

• Start date: 2023-11-06
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-08-16
• Last updated: 2025-03-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study