Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System (NCT03800563) | Clinical Trial Compass
CompletedNot Applicable
Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System
United States, Israel20 participantsStarted 2018-11-06
Plain-language summary
Multi-center, prospective, open-label, single arm study. The study aims to evaluate the safety and efficacy of Laser Assisted Liposuction procedure performed with the LipoLife system. The study will include twenty (20) eligible subjects, that are willing to undergo abdominal or outer thighs laser-assisted liposuction. Five to twenty (5-20) subjects out of this study group should also be eligible for facial fat grafting. Follow up visits to evaluate study endpoints will take place at 1, 3 and 6 months after the surgery.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects with excessive fat in the lower abdomen or subjects with excessive fat in the outer thighs that are willing to undergo laser-assisted liposuction
* Estimated fat harvesting of 1-3 liters
* Subjects (5-20) eligible for facial fat grafting of at least 5 cc for each cheek
* Between 18 and 70 years of age
* Provided written Informed Consent
Exclusion Criteria:
* Body Mass Index (BMI) \>35
* Sever skin laxity
* Positive pregnancy test
* Current smoker
* Presence of known malignancy
* Active infection in the treatment area
* History of autoimmune disorder (e.g., Systemic Lupus Erythematosus \[SLE\])
* History of connective, metabolic or atrophic skin disease
* History of keloid scarring
* Chronic use (\>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days prior to enrollment
* Subjects with immune system diseases
* Subject unable to follow post-treatment instructions
* Any other reason that in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correct Identification of Before and After Photographs