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Prospective Comparison of Revolve™ and AuraGen 123 With AuraClens™ in Autologous Fat Grafting to the Breast

NCT04906811 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-02-14

No results posted yet for this study

Summary

The purpose of this study is to compare fat graft retention over time from lipoaspirate processed using two FDA-cleared devices: the Revolve System (K120902) and the AuraGen 1-2-3 with AuraClens Lipoaspirate Wash System (BK190433).

Conditions

  • Autologous Fat Grafting

Interventions

DEVICE

AuraGen 1-2-3 with AuraClens system (BK190433)

Fat grafting to the breast in patients undergoing an aesthetic procedure without a breast implant. Device used: AuraGen 1-2-3 with AuraClens system

DEVICE

Revolve System (K120902)

Fat grafting to the breast in patients undergoing an aesthetic procedure without a breast implant. Device used: Revolve System

Sponsors & Collaborators

  • AuraGen Aesthetics LLC

    lead INDUSTRY

Principal Investigators

  • Daniel A Del Vecchio, MD · Back Bay Plastic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2024-02-12
Completion
2024-02-12
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04906811 on ClinicalTrials.gov