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OpenTrials
Completed

NCT Number: NCT03800563

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.

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Key information

Conditions

Laser Assisted Liposuction

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yitzhak Shamir Medical Center, Be’er Ya‘aqov, Israel

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LipoLife system

Device

Abdominal/ Outer thighs Laser Assisted Liposuction. Five to twenty subjects out of the study group will also undergo facial fat grafting.

Primary outcomes

  1. Correct Identification of Before and After Photographs

    Time frame: 3 months

    Over 90% success in correct identification of before and after body contouring photos by blinded evaluators.

Sponsors and collaborators

Lead sponsor

Alma Lasers

Industry

Registry information

Official study title

The Safety and Efficacy of Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 11, 2019
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.