Tightening of Skin LaxityEarly Phase 1NCT00662389
Application of the Apsara Thermal Wand System
A Early Phase 1 study testing Apsara Thermal Wand System in people with Tightening of Skin Laxity, run by Apsara Medical Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tightening of Skin Laxity
- What is being tested?
- Apsara Thermal Wand System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Mar 2009
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nonsmoker
- Glogau class 1-3
- Previously chosen to undergo facelift
Who cannot join
- Pregnant, nursing
- Implanted electro-mechanical device
- Allergy to anesthesia or device metals
- Collagen vascular disease
- History of keloid or hypertrophic scar formation
- Uncontrolled diabetes
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Bryant A. Toth, MD, FACS
San Francisco, California, 94115
About this study
Official title: TP-1013 Pilot 1: 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.
- Conditions
- Tightening of Skin Laxity
- Being tested
- Apsara Thermal Wand System
- Keywords
- skin laxity, wrinkles, rhytids
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apsara Thermal Wand SystemDevice
Single radiofrequency cycle to dermal tissue
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: Apsara Thermal Wand System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events
Number of Serious Adverse Events
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tightening of Skin LaxityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apsara Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662389
- Sponsor's protocol ID
- NEIRB08-090
- Status last verified
- Jul 2009
- First submitted
- 17 Apr 2008
- Last updated
- 28 Aug 2009
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TP-1013 Pilot 1: Application of the Apsara Thermal Wand System
- ClinicalTrials.gov ID
- NCT00662389
- Acronym / sponsor ID
- NEIRB08-090
- Conditions
- Tightening of Skin Laxity
- Keywords
- skin laxity, wrinkles, rhytids
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Apsara Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Posted 28 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Apsara Thermal Wand System |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Nonsmoker
- Glogau class 1-3
- Previously chosen to undergo facelift
Key exclusion criteria (10 listed)
- Pregnant, nursing
- Implanted electro-mechanical device
- Allergy to anesthesia or device metals
- Collagen vascular disease
- History of keloid or hypertrophic scar formation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apsara Thermal Wand SystemSingle radiofrequency cycle to dermal tissue | Device | A |
Primary outcome
Serious Adverse Events
Time frame: Immediate
Number of Serious Adverse Events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Apsara Thermal Wand System in people with Tightening of Skin Laxity, run by Apsara Medical Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2009.