NCT05016674

Brief Summary

Single-center, prospective, open-label study. The study aims to assess the structure and viability of fat collected during the LipoLife liposuction procedure

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

September 5, 2024

Status Verified

September 1, 2024

Enrollment Period

1.5 years

First QC Date

August 17, 2021

Last Update Submit

September 4, 2024

Conditions

Laser Assisted Liposuction

Outcome Measures

Primary Outcomes (1)

  • Average adipose cell cluster size

    Assessment of adipose cell cluster size by microscope

    6 months

Study Arms (1)

Laser-assisted liposuction

EXPERIMENTAL

Laser-Assisted Liposuction with the LipoLife system.

Device: LipoLife system

Interventions

LipoLife systemDEVICE

Abdominal Laser-Assisted Liposuction

Laser-assisted liposuction

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Jason Martin, MD

Denver, Colorado, 80206, United States

Location

Study Officials

  • William Jason Martin, MD

    Jason Martin, M.D.

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2021

First Posted

August 23, 2021

Study Start

July 21, 2021

Primary Completion

February 1, 2023

Study Completion

May 1, 2023

Last Updated

September 5, 2024

Record last verified: 2024-09

Locations

US(1)