An interventional study of Venus Freeze (MP2 V2 System in Wrinkled Structure and Circumference Reduction, sponsored by Venus Concept. Completed at 1 site in Israel. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-16.
Sponsored by Venus Concept · Not applicable, Interventional, and Treatment
Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis and hypodermis.
Radio-frequency (RF) devices have been used for many years for a variety of surgical applications. The energy delivery systems of these established monopolar devices used a 'conductive coupling' delivery system in which energy is concentrated at the periphery of the electrode.
Venus Concept has developed the Venus Freeze (MP)2 V2 system for wrinkles, rhytides and temporary cellulite and circumference reduction treatments. While treating wrinkles rhytides and cellulite, the treatments creates enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis or dermis.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 60 is above the median of 34 across 65 interventional studies indexed under Cellulite.
Browse Cellulite studies →Venus Concept is the lead sponsor of 34 studies on the registry; 4 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 12 (92%) have results posted.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Venus Freeze (MP)2 V2 system
Device: Venus Freeze (MP2 V2 System
Sham comparator
Device: Venus Freeze (MP2 V2 System
Facial wrinkles and temporary cellulite and circumference reduction treatments
To evaluate the efficacy of the Venus system for wrinkles rhytides and temporary cellulite and circumference reduction treatment. Efficacy evaluation will include RF, Magnetic Pulse Field and vacuum technology.
Efficacy will be established by skin improvement as a result of the treatment by validated scales. Results will be compared to control group results. The pre - and post-treatment photographs will be compared and assessed by three independent dermatologists.
Time frame: 5 months
To evaluate the safety of the Venus Freeze (MP)2 V2 system for wrinkles, rhytides, temporary cellulite and circumference reduction. Safety evaluation will include RF, Magnetic Pulse Field and vacuum technology.
Safety parameters will include adverse events (signs of pain; edema; burn; localized infection; skin pigmentation \& texture alterations) occurring as a direct result of the treatment and complaints up to last follow up visit.
Time frame: 5 months
The record gives a start of Dec 2010, a primary completion of Sep 2014 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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