Laser Assisted LiposuctionNCT03800563

Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System

A study testing LipoLife system in people with Laser Assisted Liposuction, run by Alma Lasers at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Laser Assisted Liposuction
What is being tested?: LipoLife system
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 2 sitesin 2 countries
Study dates: 6 Nov 2018to 20 May 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Body Mass Index (BMI) >35
Sever skin laxity
Positive pregnancy test
Current smoker
Presence of known malignancy
Active infection in the treatment area

Show all 13Show fewer

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.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Sanctuary Plastic Surgery
Boca Raton, Florida, 33431

Other trials in United States

Israel1 site

Yitzhak Shamir Medical Center
Be’er Ya‘aqov

Other trials in Israel

About this study

Official title: 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.

Conditions: Laser Assisted Liposuction
Being tested: LipoLife system

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03800563
Study group	Role	What they receive
Laser assisted liposuction	Experimental	Laser Assisted Liposuction with the LipoLife system. Each subject underwent laser assisted liposuction surgery w/wo facial fat grafting , using the LipoLifeTM system. Pre-surgery evaluation visit was carried out 1 week prior to the surgery. Follow up visits to evaluate safety and efficacy will take place at 1, 3 and 6 months after the surgery. Receives: Device: LipoLife system

What is being measured

The primary outcome is the main question the study is designed to answer.

Correct Identification of Before and After Photographs
Over 90% success in correct identification of before and after body contouring photos by blinded evaluators.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Nov 201820 May 2020

First posted11 Jan 2019
Study start6 Nov 2018
Primary completion10 Sep 2019
Study completion20 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Laser Assisted LiposuctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03800563
Sponsor's protocol ID: ALM-Lipo-002
Status last verified: Nov 2019
First submitted: 9 Jan 2019
Last updated: 25 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Safety and Efficacy of Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System
ClinicalTrials.gov ID: NCT03800563
Acronym / sponsor ID: ALM-Lipo-002
Conditions: Laser Assisted Liposuction
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Alma LasersIndustry (pharma, biotech, devices)
Study start: 6 Nov 2018 (actual)
Primary completion: 10 Sep 2019 (actual)
Study completion: 20 May 2020 (actual)
First posted: 11 Jan 2019 (actual)
Results: Posted 25 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Laser assisted liposuction	Experimental	Device: LipoLife systemLaser Assisted Liposuction with the LipoLife system. Each subject underwent laser assisted liposuction surgery w/wo facial fat grafting , using the LipoLifeTM system. Pre-surgery evaluation visit was carried out 1 week prior to the surgery. Follow up visits to evaluate safety and efficacy will take place at 1, 3 and 6 months after the surgery.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (13 listed)

Body Mass Index (BMI) >35
Sever skin laxity
Positive pregnancy test
Current smoker
Presence of known malignancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LipoLife systemAbdominal/ Outer thighs Laser Assisted Liposuction. Five to twenty subjects out of the study group will also undergo facial fat grafting.	Device	Laser assisted liposuction

Primary outcome

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.

Results and safety

Results posted to the registry on 25 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Laser Assisted Liposuction of Abdominal Excessive Fat	20	20

Primary outcome: Correct Identification of Before and After Photographs

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Laser Assisted Liposuction n = 20
Value	20

Adverse events

Time frame: Duration of each subject's participation was up to 8 months from enrollment to termination. Adverse events data was to be reported at any time during or after the use of the study device.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Laser Assisted Liposuction	0 of 20 (0%)	2 of 20 (10%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jason N. Pozner, M.D. principal investigator

Sanctuary Plastic Surgery

Lior Heller, M.D. principal investigator

Yitzhak Shamir Medical Center

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LipoLife system in people with Laser Assisted Liposuction, run by Alma Lasers at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correct Identification of Before and After Photographs (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03800563.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.