Port Wine StainNCT00782483
Personalized Interactive Laser Therapy of Port Wine Stain
A study testing ThermoVision A20M Infrared Camera, ScleroPLUS and 3D Digital Camera in people with Port Wine Stain, run by University of Arkansas at 1 site in United States.
Trial summary
Lasers are being used to treat Port Wine Stains (PWS), but the laser doesn't always work. Only about 10% of PWS can be completely cleared. The research team believes that the investigators can improve the response of PWS to laser therapy by using a computer program that the principal investigator of this study (Dr. Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- Port Wine Stain
- What is being tested?
- ThermoVision A20M Infrared Camera, ScleroPLUS and 3D Digital Camera
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Oct 2012
- Phase
- Interventional
- 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 3 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with a PWS
- At least one visible PWS measuring greater than or equal to 15 mm in diameter.
- Information provided regarding alternative treatment methods, includig no treatment.
- Reading, understanding, and signing of an informed consent document.
- Children age 7 years or older has read, understood, and signed an assent document.
- Agreement to participate in the study.
- Agreement to return to at least 1 follow-up evaluation and treatment within 1 year after first treatment.
- Zubrod performance status of 0 or 1 at screening.
Who cannot join
- Inability or unwillingness of subject to participate in the study.
- Inability or unwillingness of one parent or legal guardian of the subject to sign written informed consent document.
- Subject can not return to at least 1 follow-up visit within 1 year, after the first treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
Official title: Personalized Interactive Laser Therapy of Port Wine Stain - Study 2
Lasers are being used to treat Port Wine Stains (PWS), but the laser doesn't always work. Only about 10% of PWS can be completely cleared. The research team believes that the investigators can improve the response of PWS to laser therapy by using a computer program that the principal investigator of this study (Dr. Shafirstein PhD) has developed. The purpose of this study is to test the validity of this computer program. Personalized Interactive Laser Therapy (PILT) could significantly improve clinical outcomes of laser treatment of PWS.
- Conditions
- Port Wine Stain
- Being tested
- ThermoVision A20M Infrared Camera, ScleroPLUS, 3D Digital Camera
- Keywords
- Diagnosis, Port Wine Stain, PWS
- Medical subject headings
- Port-Wine Stain, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermoVision A20M Infrared CameraDevice
FLIR Systems, Boston, MA. This is a non invasive passive thermal imaging device with less than minimal risk to subjects and staff.
ScleroPLUSDevice
Sclerolaser, Candela Corp., Wayland, MA. This laser is approved by the food and drug administration (FDA) for treating PWS lesions and will be used as labeled.
3D Digital CameraDevice
3dMD, Atlanta, GA. Approved by the food and drug administration (FDA) for imaging patients and will be used as labeled.
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Laser Setting to be Used to Treat Port Wine Stains as Measured by Mathematical Calculations Based on Imaging and Temperature Analysis of Malformation.
6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.
Measured: Three treatments up to one year, whichever is first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: PI moved out of state.
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 Port Wine StainStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Arkansas Children's Hospital Research Institute, Children's University Medical Group
- Responsible party
- Sponsor
- Investigators
- Gal Shafirstein, PhD, Principal investigator, UAMS, ACH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782483
- Sponsor's protocol ID
- 104344
- Other IDs
- UAMS Sponsored
- Status last verified
- Jun 2014
- First submitted
- 29 Oct 2008
- Last updated
- 21 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Interactive Laser Therapy of Port Wine Stain - Study 2
- ClinicalTrials.gov ID
- NCT00782483
- Acronym / sponsor ID
- 104344
- Conditions
- Port Wine Stain
- Keywords
- Diagnosis, Port Wine Stain, PWS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI moved out of state.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Arkansas Children's Hospital Research Institute, Children's University Medical Group
- Study start
- Oct 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Posted 21 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lasers are being used to treat Port Wine Stains (PWS), but the laser doesn't always work. Only about 10% of PWS can be completely cleared. The research team believes that the investigators can improve the response of PWS to laser therapy by using a computer program that the principal investigator of this study (Dr. Shafirstein PhD) has developed. The purpose of this study is to test the validity of this computer program. Personalized Interactive Laser Therapy (PILT) could significantly improve clinical outcomes of laser treatment of PWS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Diagnosed with a PWS
- At least one visible PWS measuring greater than or equal to 15 mm in diameter.
- Information provided regarding alternative treatment methods, includig no treatment.
- Reading, understanding, and signing of an informed consent document.
- Children age 7 years or older has read, understood, and signed an assent document.
Key exclusion criteria (3 listed)
- Inability or unwillingness of subject to participate in the study.
- Inability or unwillingness of one parent or legal guardian of the subject to sign written informed consent document.
- Subject can not return to at least 1 follow-up visit within 1 year, after the first treatment.
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 |
|---|---|---|
| ThermoVision A20M Infrared CameraFLIR Systems, Boston, MA. This is a non invasive passive thermal imaging device with less than minimal risk to subjects and staff. | Device | – |
| ScleroPLUSSclerolaser, Candela Corp., Wayland, MA. This laser is approved by the food and drug administration (FDA) for treating PWS lesions and will be used as labeled. | Device | – |
| 3D Digital Camera3dMD, Atlanta, GA. Approved by the food and drug administration (FDA) for imaging patients and will be used as labeled. | Device | – |
Primary outcome
Average Laser Setting to be Used to Treat Port Wine Stains as Measured by Mathematical Calculations Based on Imaging and Temperature Analysis of Malformation.
Time frame: Three treatments up to one year, whichever is first
6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
- 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.
Gal Shafirstein, PhD principal investigator
UAMS, ACH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ThermoVision A20M Infrared Camera, ScleroPLUS and 3D Digital Camera in people with Port Wine Stain, run by University of Arkansas 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 8 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: stopped early, as of the sponsor's last update on 21 Jul 2014. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2014). 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?
Average Laser Setting to be Used to Treat Port Wine Stains as Measured by Mathematical Calculations Based on Imaging and Temperature Analysis of Malformation. (time frame: Three treatments up to one year, whichever is first). 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 21 Jul 2014.