Assessment of Cellular and Tissue Characteristics in Lipoaspirates Stirred by VorFat

NCT ID: NCT05016674

Last Updated: 2024-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-21

Study Completion Date

2023-05-01

Brief Summary

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

Detailed Description

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Conditions

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Laser Assisted Liposuction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laser-assisted liposuction

Laser-Assisted Liposuction with the LipoLife system.

Group Type EXPERIMENTAL

LipoLife system

Intervention Type DEVICE

Abdominal Laser-Assisted Liposuction

Interventions

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LipoLife system

Abdominal Laser-Assisted Liposuction

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Between 18 and 70 years of age.
3. Estimated fat harvesting of at least 300 milliliters.
4. Provided written Informed Consent.

Exclusion Criteria

1. Pregnant or intending to become pregnant during the course of study.
2. Current smoker.
3. Presence of known malignancy.
4. Active infection in the treatment area.
5. History of autoimmune disorder (e.g., Systemic Lupus Erythematosus \[SLE\]).
6. History of connective, metabolic, or atrophic skin disease.
7. History of keloid scarring.
8. Chronic use (\>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days before enrollment.
9. Subjects with immune system diseases.
10. Any other reason that in the opinion of the investigator, prevents the subject from participating in the study or compromises the subject safety.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alma Lasers

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Jason Martin, MD

Role: PRINCIPAL_INVESTIGATOR

Jason Martin, M.D.

Locations

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William Jason Martin, MD

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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ALM-Lipo-VorFat-21-013

Identifier Type: -

Identifier Source: org_study_id

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