Laser Assisted LiposuctionNCT05016674
Assessment of Cellular and Tissue Characteristics in Lipoaspirates Stirred by VorFat
A study testing LipoLife system in people with Laser Assisted Liposuction, run by Alma Lasers at 1 site in United States.
Trial summary
Single-center, prospective, open-label study. The study aims to assess the structure and viability of fat collected during the LipoLife liposuction procedure Read more about this study
- 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2021to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 scheduled to undergo abdominal w/wo flanks laser-assisted liposuction surgery and are willing to donate the harvested adipose tissue for the study assessment.
- Between 18 and 70 years of age.
- Estimated fat harvesting of at least 300 milliliters.
- Provided written Informed Consent.
Who cannot join
- Pregnant or intending to become pregnant during the course of study.
- 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.
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- History of keloid scarring.
- Chronic use (>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days before enrollment.
- Subjects with immune system diseases.
- Any other reason that in the opinion of the investigator, prevents the subject from participating in the study or compromises the subject safety.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Cellular and Tissue Characteristics in Lipoaspirates Harvested With the LipoLife System and Stirred by VorFat
Single-center, prospective, open-label study. The study aims to assess the structure and viability of fat collected during the LipoLife liposuction procedure
- 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 Laser-Assisted Liposuction
| Study group | Role | What they receive |
|---|---|---|
| Laser-assisted liposuction | Experimental | Laser-Assisted Liposuction with the LipoLife system. Receives: Device: LipoLife system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average adipose cell cluster size
Assessment of adipose cell cluster size by microscope
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start21 Jul 2021
- Primary completion1 Feb 2023 (estimated)
- Study completion1 May 2023 (estimated)
Why it stopped: no recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alma Lasers
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Jason Martin, MD, Principal investigator, Jason Martin, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016674
- Sponsor's protocol ID
- ALM-Lipo-VorFat-21-013
- Status last verified
- Sep 2024
- First submitted
- 17 Aug 2021
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cellular and Tissue Characteristics in Lipoaspirates Harvested With the LipoLife System and Stirred by VorFat
- ClinicalTrials.gov ID
- NCT05016674
- Acronym / sponsor ID
- ALM-Lipo-VorFat-21-013
- Conditions
- Laser Assisted Liposuction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alma LasersIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-center, prospective, open-label study. The study aims to assess the structure and viability of fat collected during the LipoLife liposuction procedure
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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects scheduled to undergo abdominal w/wo flanks laser-assisted liposuction surgery and are willing to donate the harvested adipose tissue for the study assessment.
- Between 18 and 70 years of age.
- Estimated fat harvesting of at least 300 milliliters.
- Provided written Informed Consent.
Key exclusion criteria (10 listed)
- Pregnant or intending to become pregnant during the course of study.
- Current smoker.
- Presence of known malignancy.
- Active infection in the treatment area.
- History of autoimmune disorder (e.g., Systemic Lupus Erythematosus [SLE]).
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 Laser-Assisted Liposuction | Device | Laser-assisted liposuction |
Primary outcome
Average adipose cell cluster size
Time frame: 6 months
Assessment of adipose cell cluster size by microscope
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
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.
William Jason Martin, MD principal investigator
Jason Martin, M.D.
1 site in 1 country: 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 1 site in United States.
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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Average adipose cell cluster size (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2024.