Application of the Apsara Thermal Wand System

Apsara Medical

Status and phase: Completed; Early Phase 1

Conditions: Tightening of Skin Laxity

Treatments: Device: Apsara Thermal Wand System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00662389

NEIRB08-090

Details and patient eligibility

About

The purpose of this feasibility study is to gain an initial assessment of the acute safety and performance of the Apsara Thermal Wand System in human facial tissue.

Enrollment: 4 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Nonsmoker
• Glogau class 1-3
• Previously chosen to undergo facelift

Exclusion criteria

• Pregnant, nursing
• Implanted electro-mechanical device
• Allergy to anesthesia or device metals
• Collagen vascular disease
• History of keloid or hypertrophic scar formation
• Uncontrolled diabetes
• Long term steroid or other immunologic inhibitor use
• Previous treatment to target area
• Does not consent to study
• Does not consent to photography or histological evaluation

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

A

Experimental group

Treatment:

Device: Apsara Thermal Wand System