AV-23-001 AVAVA MIRIA Pilot Study
NCT06557434 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-03-07
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.
Conditions
- Wrinkle
- Acne Scars - Mixed Atrophic and Hypertrophic
- Pigmented Lesions
- Skin Laxity
- Scars
Interventions
- 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.
Sponsors & Collaborators
-
AVAVA, Inc.
lead INDUSTRY
Principal Investigators
-
Hyemin Pomerantz, MD · AVAVA, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-11-06
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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