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Completed

NCT Number: NCT00662389

Application of the Apsara Thermal Wand System

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.

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Key information

Conditions

Tightening of Skin Laxity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Genetic Diseases, Inborn Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Bryant A. Toth, MD, FACS

San Francisco, California, 94115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apsara Thermal Wand System

Device

Single radiofrequency cycle to dermal tissue

Primary outcomes

  1. Serious Adverse Events

    Time frame: Immediate

    Number of Serious Adverse Events

Sponsors and collaborators

Lead sponsor

Apsara Medical Corporation

Industry

Registry information

Official study title

TP-1013 Pilot 1: Application of the Apsara Thermal Wand System

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 21, 2008
Registry last updated
Aug 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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