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AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast

NCT05258305 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-12-04

No results posted yet for this study

Summary

Prospective, multi-center, non-randomized, open-label, post-market clinical study evaluating adipose graft retention over time from lipoaspirate processed using the AuraGen 1-2-3™ with AuraClens™ Lipoaspirate Wash System.

Conditions

  • Breast Fat Grafting Retention

Interventions

DEVICE

AuraGen 1-2-3 with AuraClens

Autologous fat transfer (AFT) is a minimally invasive medical procedure that includes aspirating adipose tissue from one part of the body, and washing, filtering and re-injecting the processed fat tissue into a different part of the body with the primary purpose of adding volume. The AuraGen 1-2-3 with AuraClens is a lipoaspirate wash system designed to be used in the operating room in conjunction with a user-provided liposuction cannular, a vacuum source, and waste canister.

Sponsors & Collaborators

  • Tiger Biosciences, LLC.

    lead INDUSTRY

Principal Investigators

  • Denise Dajles, PhD · Tiger Biosciences, LLC.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-05
Primary Completion
2024-11-30
Completion
2024-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05258305 on ClinicalTrials.gov