Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 1/13/2019 |
| Start Date: | November 6, 2018 |
| End Date: | December 2019 |
| Contact: | Jason N. Pozner, M.D. |
| Email: | drpozner@spsboca.com |
| Phone: | 561-367-9101 |
The Safety and Efficacy of Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System
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.
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.
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.
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