Cosmetic ProceduresNCT02200471
Cosmetic Dermatology Study
A study testing VeinViewer in people with Cosmetic Procedures, run by Christie Medical Holdings, Inc. at 2 sites in United States.
Trial summary
This study aims to understand the impact of VeinViewer technology during routine cosmetic and dermatologic procedures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cosmetic Procedures
- What is being tested?
- VeinViewer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age and up
- Male or Female
- Receiving cosmetic dermatological injection
- Willing to participate
Who cannot join
- Aged younger than 18 years
- Prior history of known light sensitivity
- Other reasons as determined by investigator
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MD Laser Skin & Vein Institute
Hunt Valley, Maryland, 21030
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
La Jolla, California, 92121
About this study
Official title: Evaluation of VeinViewer in Cosmetic Dermatology
This study aims to understand the impact of VeinViewer technology during routine cosmetic and dermatologic procedures.
Read the detailed description
This study was designed as an observational study to determine if VeinViewer technology helped to improve the efficiency of certain dermatological procedures namely botox injections and schlerotherapy for varicose veins. The device was used to identify veins but clinical decisions were ultimately left the physician.
- Conditions
- Cosmetic Procedures
- Being tested
- VeinViewer
- Keywords
- Cosmetic dermatology, near-infrared, patient preference, physician preference
- Medical subject headings
- Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeinViewerDevice
| Study group | Role | What they receive |
|---|---|---|
| VeinViewer | Experimental | VeinViewer will be used in conjunction with routine cosmetic dermatology procedures. Patients and physicians will complete questionnaires. Receives: Device: VeinViewer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient perception of the use of the device
Small questionnaires will be used to assess how the patient perceives the use of the device (i.e., did the patient have a positive attitude towards the device?)
Measured: Day 1
Secondary outcomes (1)
Physician perception of the use of the device
Physicians will complete a small questionnaire to understand what their perception of the use of the device to be (i.e, did the physician have a positive attitude towards the device while using it).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cosmetic ProceduresStudies 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christie Medical Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200471
- Sponsor's protocol ID
- SPN - 13 / 04 - 01
- Status last verified
- Oct 2018
- First submitted
- 21 Jul 2014
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of VeinViewer in Cosmetic Dermatology
- ClinicalTrials.gov ID
- NCT02200471
- Acronym / sponsor ID
- SPN - 13 / 04 - 01
- Conditions
- Cosmetic Procedures
- Keywords
- Cosmetic dermatology, near-infrared, patient preference, physician preference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Christie Medical Holdings, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to understand the impact of VeinViewer technology during routine cosmetic and dermatologic procedures.
Detailed description
This study was designed as an observational study to determine if VeinViewer technology helped to improve the efficiency of certain dermatological procedures namely botox injections and schlerotherapy for varicose veins. The device was used to identify veins but clinical decisions were ultimately left the physician.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VeinViewer | Experimental | Device: VeinViewerVeinViewer will be used in conjunction with routine cosmetic dermatology procedures. Patients and physicians will complete questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age and up
- Male or Female
- Receiving cosmetic dermatological injection
- Willing to participate
Key exclusion criteria (3 listed)
- Aged younger than 18 years
- Prior history of known light sensitivity
- Other reasons as determined by investigator
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 |
|---|---|---|
| VeinViewer | Device | VeinViewer |
Primary outcome
Patient perception of the use of the device
Time frame: Day 1
Small questionnaires will be used to assess how the patient perceives the use of the device (i.e., did the patient have a positive attitude towards the device?)
1 secondary outcome
Physician perception of the use of the device
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VeinViewer in people with Cosmetic Procedures, run by Christie Medical Holdings, Inc. at 2 sites 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 4 inclusion and 3 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 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient perception of the use of the device (time frame: Day 1). 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 17 Oct 2018.