Port-wine Stains (PWS)TALDINCT01759082
The Angioma's Treatment Evaluation With Laser Doppler Imaging (LDI)
An observational study of Port-wine Stains (PWS), run by University of Lausanne Hospitals.
Trial summary
Based on the Doppler effect, Laser Doppler Imaging (LDI) uses the interaction of light with moving erythrocytes to visualize perfusion in the microcirculatory system. The new device to be used in this study have been adapted specifically for the application, facilitating its use in clinic. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Port-wine Stains (PWS)
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Oct 2013
- Phase
- Observational
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: * Subjects presenting at the CHUV with PWS will be screened and their parents asked to join the study by a member of the research team. * Subjects who meet the inclusion criteria will be approached for informed written consent and enrolled in the study.
Who may be able to join
- children aged 12 months to 6 years old
- port-wine stains (PWS)
- phototype's skin I, II or III
Who cannot join
- phototype's skin IV, V or VI
- prior treatment with laser
- contraindication of general anesthesia
- refusal from the parents
About this study
Based on the Doppler effect, Laser Doppler Imaging (LDI) uses the interaction of light with moving erythrocytes to visualize perfusion in the microcirculatory system.
The new device to be used in this study have been adapted specifically for the application, facilitating its use in clinic. It has been designed to take a standard white light image of the area under inspection simultaneously with the perfusion image to facilitate clinical assessment.
Read more
Port-wine stain (PWS) birthmarks are congenital, low-flow vascular malformations of the skin found in approximately 0.3% of children. They are commonly found on the face and neck and may cause serious psychological consequences.
Lasers are the modality of choice for the treatment of PWS birthmarks. The use of PDL is very effective in PWS in closing the blood vessels and diminishing therefore the redness of the skin. Repeated laser treatment is necessary to achieve the desired clinical outcome.
Actually, the efficacy of the treatment of PWS by the laser is obtained by clinical inspection and digital photography.
By measuring the activity and intensity of the microcirculation present in and under the skin, the Laser-Doppler (LDI) will be capable of measuring the effect of Pulsed dye laser (PDL) treatment for port-wine stains.
- Conditions
- Port-wine Stains (PWS)
- Medical subject headings
- Port-Wine Stain
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascularization's percentage of the PWS with Laser Doppler
After the general anesthesia, we will take a measure before the treatment with the Laser Doppler of the vascularization's percentage of the PWS relative as the safe contralateral side.
An other measure will be made after the treatment.
Measured: For each treatment, spaced about 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Port-wine Stains (PWS)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tessa Mermod, University of Lausanne Hospitals
- Investigators
- Anthony DeBuys Roessingh, Dr MD PhD, Principal investigator, Paediatrics Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759082
- Sponsor's protocol ID
- CHP
- Acronym
- TALDI
- Status last verified
- Dec 2012
- First submitted
- 2 Dec 2012
- Last updated
- 2 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Angioma's Treatment Evaluation With Laser Doppler Imaging (LDI)
- ClinicalTrials.gov ID
- NCT01759082
- Acronym / sponsor ID
- TALDI / CHP
- Conditions
- Port-wine Stains (PWS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 2 Jan 2013 (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.
Based on the Doppler effect, Laser Doppler Imaging (LDI) uses the interaction of light with moving erythrocytes to visualize perfusion in the microcirculatory system.
The new device to be used in this study have been adapted specifically for the application, facilitating its use in clinic. It has been designed to take a standard white light image of the area under inspection simultaneously with the perfusion image to facilitate clinical assessment.
Port-wine stain (PWS) birthmarks are congenital, low-flow vascular malformations of the skin found in approximately 0.3% of children. They are commonly found on the face and neck and may cause serious psychological consequences.
Lasers are the modality of choice for the treatment of PWS birthmarks. The use of PDL is very effective in PWS in closing the blood vessels and diminishing therefore the redness of the skin. Repeated laser treatment is necessary to achieve the desired clinical outcome.
Actually, the efficacy of the treatment of PWS by the laser is obtained by clinical inspection and digital photography.
By measuring the activity and intensity of the microcirculation present in and under the skin, the Laser-Doppler (LDI) will be capable of measuring the effect of Pulsed dye laser (PDL) treatment for port-wine stains.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- * Subjects presenting at the CHUV with PWS will be screened and their parents asked to join the study by a member of the research team. * Subjects who meet the inclusion criteria will be approached for informed written consent and enrolled in the study.
Key inclusion criteria (3 listed)
- children aged 12 months to 6 years old
- port-wine stains (PWS)
- phototype's skin I, II or III
Key exclusion criteria (4 listed)
- phototype's skin IV, V or VI
- prior treatment with laser
- contraindication of general anesthesia
- refusal from the parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vascularization's percentage of the PWS with Laser Doppler
Time frame: For each treatment, spaced about 2 months
After the general anesthesia, we will take a measure before the treatment with the Laser Doppler of the vascularization's percentage of the PWS relative as the safe contralateral side. An other measure will be made after the treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2013.
Related trials for Port-wine Stains (PWS)
Recruiting
AdvaTx Laser Treatment for Vascular Birthmarks
Port-wine Stains (PWS), Vascular Birthmark
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.
Anthony DeBuys Roessingh, Dr MD PhD principal investigator
Paediatrics Surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Port-wine Stains (PWS), run by University of Lausanne Hospitals.
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 4 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: status not confirmed, as of the sponsor's last update on 2 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Vascularization's percentage of the PWS with Laser Doppler (time frame: For each treatment, spaced about 2 months). 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 2 Jan 2013.