CClinicalTrials.gg
CompletedNCT00662389Updated Aug 28, 2009Results posted

Application of the Apsara Thermal Wand System

An Early Phase 1 interventional study of Apsara Thermal Wand System in Tightening of Skin Laxity, sponsored by Apsara Medical Corporation. Completed at 1 site in United States. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-08-28.

Sponsored by Apsara Medical Corporation · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
4
Allocation
Non-randomized
Ages
40 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Tightening of Skin Laxity

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Keywords

  • skin laxity, wrinkles, rhytids
03

In context

Cutis Laxa

147 studies on the registry are indexed under Cutis Laxa; 35 are open to participants now.

This study's enrollment of 4 is below the median of 30 across 129 interventional studies indexed under Cutis Laxa.

Browse Cutis Laxa studies →

Lead sponsor

This is the only study on the registry with Apsara Medical Corporation as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    A

    Device: Apsara Thermal Wand System

Interventions

  • DeviceApsara Thermal Wand System

    Single radiofrequency cycle to dermal tissue

06

What researchers measure

Primary outcomes

  1. Serious Adverse Events

    Number of Serious Adverse Events

    Time frame: Immediate

07

Results

Posted Aug 28, 2009

Participant flow

Participant flow — Overall Study
MilestoneA--Thermal Wand Application
Started4
Completed4
Not completed0

Outcome measures

PrimarySerious Adverse Events

Number of Serious Adverse Events

Time frame:
Immediate
Reported as:
Number · Number of Serious Adverse Events
Serious Adverse Events
Number of Serious Adverse EventsA--Thermal Wand Application
Serious Adverse Events0

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)A--Thermal Wand Application
<=18 years0
Between 18 and 65 years3
>=65 years1
Age Continuous
Age Continuous(years)A--Thermal Wand Application
Mean61.7 ± 3.6
Sex: Female, Male
Sex: Female, Male(Participants)A--Thermal Wand Application
Female4
Male0
Region of Enrollment
Region of Enrollment(participants)A--Thermal Wand Application
United States4
08

Study locations

1 site
  • Bryant A. Toth, MD, FACS
    San Francisco, California 94115, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00662389
Lead sponsor
Apsara Medical Corporation
First posted
Apr 21, 2008
Start date
Apr 2008
Primary completion
Mar 2009
Completion
Mar 2009
Results posted
Aug 28, 2009
Last update
Aug 28, 2009
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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