TelangiectasesNCT00247299
Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform
A study testing IPL Quantum Product manufactured by Luminis Ltd. in people with Telangiectases and Port Wine Stain, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The Intense Pulsed Light (IPL) technology, by selective phototermolysis, is used for eliminating, among other application, benign vascular lesions and unwanted leg veins. Light energy heats the deeper structures of the skin. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Telangiectases, Port Wine Stain
- What is being tested?
- IPL Quantum Product manufactured by Luminis Ltd.
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- May 2005to not given
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Subjects, presenting with at least one of the clinical indications mentioned above
- Willing and being able to comply with all visit and evaluation requirements
- Willing and being able to provide signed Informed Consent
Who cannot join
- A history of keloid scar formation or poor wound healing
- Wounded or tanned in area to be treated
- Pregnant or intending to become pregnant during the evaluation period
- Subjects with a bleeding disorder or who take anticoagulation medications
- Significant concurrent illnesses, such as diabetes, epilepsy, lupus or congestive heart failure
- Significant concurrent skin conditions affecting area to be treated
- Having a history of skin cancer or any other cancer in the area to be treated
- History of immunosuppressive disease
Trial locations and contacts
1 site in 1 country.
About this study
The Intense Pulsed Light (IPL) technology, by selective phototermolysis, is used for eliminating, among other application, benign vascular lesions and unwanted leg veins. Light energy heats the deeper structures of the skin. IPL devices provide a broad wavelength spectrum of 515 to 1200 nm and fluence from 10 to 40 J/cm at o.5-1 Hz.The light is focused by a reflector and then transmitted through various filters that cut off the lower wavelength range of the emitted light; therefore, only those wavelengths longer than these of the filters are transmitted.
objectives:
- evaluate and optimize the clinical performance of the Luminis ONE platform for each of the aforementioned clinical applications.
- Reconfirm the parameter settings for each of the aforementioned clinical applications.
- Confirm the user friendly design of the device, in aspects of software (user interface) and various technical operational features.
Read the detailed description
Background:
The Intense Pulsed Light (IPL) technology, by selective phototermolysis, is used for eliminating, among other application, benign vascular lesions and unwanted leg veins. Light energy heats the deeper structures of the skin. IPL devices provide a broad wavelength spectrum of 515 to 1200 nm and fluence from 10 to 40 J/cm at o.5-1 Hz.The light is focused by a reflector and then transmitted through various filters that cut off the lower wavelength range of the emitted light; therefore, only those wavelegths longer than these of the filters are transmitted.
Material and Methods:
The luminis ONE medical system (Lumenis Ltd., Yokneam,Israel, and Pleasanton, CA, USA) incorporate the non coherent pulsed light head.
Vascular lesion such as Telangiectases, leg veins or PWS will be treated with the IPL, with the following filters :515,50,or 590.
Following every treatment the subjects will be asked how much pain was felt , using a score of 1-5.
Photographs will be taken before each treatments . Every subject will be treated 5 treatments , with 5+1 weeks interval. clearance or improvement will be evaluated by the physician at each visit,before the next treatment using the following scale:
- No clearance
- 0-25%
- 25-50%
- 50-75%
- 75-100%
- Conditions
- Telangiectases, Port Wine Stain
- Being tested
- IPL Quantum Product manufactured by Luminis Ltd.
- Keywords
- Vascular lesions, Intense pulse light, phototermolysis, wavelength, filters, non coherent
- Medical subject headings
- Telangiectasis, Port-Wine Stain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPL Quantum Product manufactured by Luminis Ltd.Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Every subject will be treated 5 treatments , with 5+1 weeks interval.
clearance or improvement will be evaluated by the physician at each visit,before the next treatment using the following scale:
1. No clearance
2. 0-25%
3. 25-50%
4. 50-75%
5. 75-100%
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelangiectasesStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Lumenis Be Ltd.
- Investigators
- Yehuda Ullmann, MD, Principal investigator, Plastic Surgery Dept., Rambam Medical Center., Haifa,Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247299
- Sponsor's protocol ID
- danaCTIL
- Other IDs
- danaCTIL
- Status last verified
- Oct 2005
- First submitted
- 30 Oct 2005
- Last updated
- 1 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform
- ClinicalTrials.gov ID
- NCT00247299
- Acronym / sponsor ID
- danaCTIL
- Conditions
- Telangiectases, Port Wine Stain
- Keywords
- Vascular lesions, Intense pulse light, phototermolysis, wavelength, filters, non coherent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Lumenis Be Ltd.
- Study start
- May 2005
- First posted
- 1 Nov 2005 (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.
The Intense Pulsed Light (IPL) technology, by selective phototermolysis, is used for eliminating, among other application, benign vascular lesions and unwanted leg veins. Light energy heats the deeper structures of the skin. IPL devices provide a broad wavelength spectrum of 515 to 1200 nm and fluence from 10 to 40 J/cm at o.5-1 Hz.The light is focused by a reflector and then transmitted through various filters that cut off the lower wavelength range of the emitted light; therefore, only those wavelengths longer than these of the filters are transmitted.
objectives:
- evaluate and optimize the clinical performance of the Luminis ONE platform for each of the aforementioned clinical applications.
- Reconfirm the parameter settings for each of the aforementioned clinical applications.
- Confirm the user friendly design of the device, in aspects of software (user interface) and various technical operational features.
Detailed description
Background:
The Intense Pulsed Light (IPL) technology, by selective phototermolysis, is used for eliminating, among other application, benign vascular lesions and unwanted leg veins. Light energy heats the deeper structures of the skin. IPL devices provide a broad wavelength spectrum of 515 to 1200 nm and fluence from 10 to 40 J/cm at o.5-1 Hz.The light is focused by a reflector and then transmitted through various filters that cut off the lower wavelength range of the emitted light; therefore, only those wavelegths longer than these of the filters are transmitted.
Material and Methods:
The luminis ONE medical system (Lumenis Ltd., Yokneam,Israel, and Pleasanton, CA, USA) incorporate the non coherent pulsed light head.
Vascular lesion such as Telangiectases, leg veins or PWS will be treated with the IPL, with the following filters :515,50,or 590.
Following every treatment the subjects will be asked how much pain was felt , using a score of 1-5.
Photographs will be taken before each treatments . Every subject will be treated 5 treatments , with 5+1 weeks interval. clearance or improvement will be evaluated by the physician at each visit,before the next treatment using the following scale:
- No clearance
- 0-25%
- 25-50%
- 50-75%
- 75-100%
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy Subjects, presenting with at least one of the clinical indications mentioned above
- Willing and being able to comply with all visit and evaluation requirements
- Willing and being able to provide signed Informed Consent
Key exclusion criteria (8 listed)
- A history of keloid scar formation or poor wound healing
- Wounded or tanned in area to be treated
- Pregnant or intending to become pregnant during the evaluation period
- Subjects with a bleeding disorder or who take anticoagulation medications
- Significant concurrent illnesses, such as diabetes, epilepsy, lupus or congestive heart failure
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 |
|---|---|---|
| IPL Quantum Product manufactured by Luminis Ltd. | Device | – |
Primary outcome
Every subject will be treated 5 treatments , with 5+1 weeks interval.
clearance or improvement will be evaluated by the physician at each visit,before the next treatment using the following scale:
1. No clearance
2. 0-25%
3. 25-50%
4. 50-75%
5. 75-100%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2005.
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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.
Yehuda Ullmann, MD principal investigator
Plastic Surgery Dept., Rambam Medical Center., Haifa,Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPL Quantum Product manufactured by Luminis Ltd. in people with Telangiectases and Port Wine Stain, run by Rambam Health Care Campus at 1 site in Israel.
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 8 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 1 Nov 2005. 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 Israel. 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?
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?
Every subject will be treated 5 treatments , with 5+1 weeks interval.. The study lists 7 primary outcomes in all. 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 1 Nov 2005.