Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247299
Status:
UNKNOWN
Last Update Posted:
2005-11-01
First Post:
2005-10-30
Brief Title:
Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
Evaluation and Optimization of the Technical and Clinical Performance of the Lumenis ONE Platform
Status:
UNKNOWN
Status Verified Date:
2005-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 IPL devices provide a broad wavelength spectrum of 515 to 1200 nm and fluence from 10 to 40 Jcm at o5-1 HzThe 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
1 evaluate and optimize the clinical performance of the Luminis ONE platform for each of the aforementioned clinical applications
2 Reconfirm the parameter settings for each of the aforementioned clinical applications
3 Confirm the user friendly design of the device in aspects of software user interface and various technical operational features
objectives
1 evaluate and optimize the clinical performance of the Luminis ONE platform for each of the aforementioned clinical applications
2 Reconfirm the parameter settings for each of the aforementioned clinical applications
3 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 Jcm at o5-1 HzThe 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 YokneamIsrael 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 51550or 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 51 weeks interval clearance or improvement will be evaluated by the physician at each visitbefore the next treatment using the following scale
1 No clearance
2 0-25
3 25-50
4 50-75
5 75-100
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 Jcm at o5-1 HzThe 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 YokneamIsrael 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 51550or 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 51 weeks interval clearance or improvement will be evaluated by the physician at each visitbefore the next treatment using the following scale
1 No clearance
2 0-25
3 25-50
4 50-75
5 75-100
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| danaCTIL | None | None | None |