Application of the Apsara Thermal Wand System

Early Phase 1CompletedNCT00662389

Apsara Medical Corporation4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tightening of Skin Laxity

Interventions

Apsara Thermal Wand SystemDEVICE

Single radiofrequency cycle to dermal tissue

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Bryant A. Toth, MD, FACS

San Francisco, California, United States

Outcomes

Primary Outcomes

Serious Adverse Events

Number of Serious Adverse Events

Time frame: Immediate

Data from ClinicalTrials.gov

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