VASER-Assisted Lipoplasty Compared With Suction-Assisted Lipoplasty

NCT ID: NCT00731354

Last Updated: 2011-06-08

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-04-30

Brief Summary

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This study is being done to compare two commonly available types of body contouring, VASER-Assisted Lipoplasty (VAL) and Suction-Assisted Lipoplasty (SAL), and to decide if one procedure is preferred by patients and/or surgeons over the other. Participants will have VAL on one side of their body and SAL on the opposite side.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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SAL

Each patient will have Suction Assisted Lipoplasty procedure on one side of the body (this will be considered the control side)

Group Type ACTIVE_COMPARATOR

Suction-assisted Lipoplasty

Intervention Type DEVICE

Standard Suction-assisted lipoplasty will be performed on one side of the body to remove excess fat and contour the body in one or more of the following body areas: arm, inner thigh, outer thigh, back

VAL

Each patient will have VASER- assisted lipoplasty on the opposite side of the body. This will be the comparison side.

Group Type ACTIVE_COMPARATOR

VASER-assisted lipoplasty

Intervention Type DEVICE

VASER-assisted lipoplasty will be performed on the opposite side of the body to remove excess fat and contour the body in one or more of the following body areas: arm, inner thigh, outer thigh, back

Interventions

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Suction-assisted Lipoplasty

Standard Suction-assisted lipoplasty will be performed on one side of the body to remove excess fat and contour the body in one or more of the following body areas: arm, inner thigh, outer thigh, back

Intervention Type DEVICE

VASER-assisted lipoplasty

VASER-assisted lipoplasty will be performed on the opposite side of the body to remove excess fat and contour the body in one or more of the following body areas: arm, inner thigh, outer thigh, back

Intervention Type DEVICE

Other Intervention Names

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Suction-assisted lipoplasty, Liposuction VAL, VASER, LipoSelection, 3rd Generation UAL

Eligibility Criteria

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Inclusion Criteria

* give voluntary, signed informed consent in accordance with institutional policies
* be between the ages of 18-50 years old
* Be willing and able to appear for all scheduled, post-operative visits with their doctor
* Have moderate to good skin tone
* Have excess fatty tissue in the arms, medial thighs, lateral thighs, or back where the extra tissue is expected to be composed of adipose tissue.
* Have a body mass index between 20-30
* Are non-smokers

Exclusion Criteria

* under the age of 18
* over the age of 50
* are undergoing boy contouring for reconstruction following injury or disease are deemed inappropriate candidates for surgery due to medical or mental health reasons
* are concurrently being treated with other investigational agents or have participated in an investigational study within 60 days prior to surgery
* elect not to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sound Surgical Technologies, LLC.

INDUSTRY

Sponsor Role lead

Responsible Party

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Sound Surgical Technologies, LLC

Principal Investigators

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Onelio Garcia, MD, F.A.C.S

Role: PRINCIPAL_INVESTIGATOR

Plastic Surgery Center of South Florida

Michael Nagy, MD, F.A.C.S

Role: PRINCIPAL_INVESTIGATOR

Personal Enhancement Center

Paul F Vanek, MD, F.A.C.S.

Role: PRINCIPAL_INVESTIGATOR

Lake Hospital Systems

Locations

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Plastic Surgery Center of South Florida

Miami, Florida, United States

Site Status

Personal Enhancement Center

Toms River, New Jersey, United States

Site Status

Paul F. Vanek, M.D., F.A.C.S.

Mentor, Ohio, United States

Site Status

Countries

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United States

Related Links

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http://www.vaser.com/

Sound Surgical Technology - technique description

Other Identifiers

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SST40.2

Identifier Type: -

Identifier Source: org_study_id

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