An interventional study of velos in Vascular Lesions and Photoaging, sponsored by Syneron Medical. Status unknown at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-06.
Sponsored by Syneron Medical · Not applicable, Interventional, and Treatment
This is a multi-center, multi-cohort, prospective, open-label study of VELOS for treatment of vascular skin disorders. The plan is to enroll up to 60 subjects from up to 3 centers in the US and worldwide. The purpose is to collect data from the use of VELOS.
The primary objective of this trial is to collect data from the use of VELOS in clinical practice under a wide range of treatment parameters variability including RF energy, laser fluence, and laser pulse duration for treating each of the vascular disorders. This will be conducted by documenting the physician selected treatment parameters, as well as the subjects' clinical clearing response, perception of improvement and sensations, through the study treatments and post-treatment(s) follow-up visits.
Optional exploratory objectives: Collection of safety and efficacy data of the Velos with DCD cooling and Velos with contact cooling. The investigator may opt to include in this study noninvasive measurements of erythema, melanin and texture (which may be performed by eg. Chromameter, Mexameter or 3D imaging), and measurements of linear vessel diameters and lesion size.
Syneron Medical is the lead sponsor of 41 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pulsed dye laser/bipolar radiofrequency (Velos) treatment of facial skin disorders including photo-damage, age spots, lentigos, solar telangiectasia and general facial telangiectasia
Device: velos
Pulsed dye laser/bipolar radiofrequency (Velos) treatment of leg veins of diameter of at least 1mm, i.e., venulectasia and reticular leg veins.
Device: velos
Pulsed dye laser/bipolar radiofrequency (Velos) treatment treatment of general skin rejuvenation including Rosacea, erythematous scars (including acne), and erythematous striae (subjects enrolled in this group must have at least two of the above mentioned treatment indications.
Device: velos
Velos (Bipolar radiofrequency only) treatment for improving skin laxity or skin tightness/firmness
Device: velos
VELOS combines 595nm pulsed dye laser energy with bipolar RF energy. The study device can deliver 0.45 to 40 ms laser pulses at a maximum of 25 J/cm2
Evidence of leg vein and skin improvement by validated vascular assessment scale and wrinkle assessment scale
Evidence of leg vein and skin improvement by validated vascular assessment scale and wrinkle assessment scale
Time frame: up to 3 months after treatment
Number and severity of all complications caused by the laser will be recorded and descriptively tabulated
Time frame: up to 3 months
Subject Improvement Questionnaire
Time frame: up to 6 months
Subject assessment of comfort level associated with treatment
Numerical Response Scale for Rating Pain (NRS)
Time frame: day 0, afer 4 weeks, 8 weeks and 12 weeks
This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Syneron Medical