NCT00731354

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for phase_4 healthy

Timeline
Completed

Started Jul 2007

Typical duration for phase_4 healthy

Geographic Reach
1 country

3 active sites

Status
completed

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 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2008

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

Enrollment Period

1.2 years

First QC Date

August 4, 2008

Last Update Submit

June 6, 2011

Conditions

Healthy

Keywords

lipoplastyliposuctionVASERbody contouringbody sculptingAny patientexpressinginterestin elective surgery

Outcome Measures

Primary Outcomes (1)

  • Investigators aim to assess outcomes associated with the two different methods to determine if one technology/technique offers superior results compared to the other.

    6 months

Secondary Outcomes (8)

  • To assess the difference in patients' post-operative pain level between the SAL side and the VAL side

    6 months

  • To assess the difference in patients' post-operative sensation level between the SAL side and the VAL side

    6 months

  • To assess the difference in post-operative patient preference between the SAL side and the VAL side

    6 months

  • To assess the difference in post-operative ecchymosis between the SAL side and the VAL side

    6 months

  • To assess the difference in post-operative skin retraction between the SAL side and the VAL side

    6 months

  • +3 more secondary outcomes

Study Arms (2)

SAL

ACTIVE COMPARATOR

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

Device: Suction-assisted Lipoplasty

VAL

ACTIVE COMPARATOR

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

Device: VASER-assisted lipoplasty

Interventions

Suction-assisted LipoplastyDEVICE

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

Also known as: Suction-assisted lipoplasty, Liposuction
SAL
VASER-assisted lipoplastyDEVICE

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

Also known as: VAL, VASER, LipoSelection, 3rd Generation UAL
VAL

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Plastic Surgery Center of South Florida

Miami, Florida, 33146, United States

Location

Personal Enhancement Center

Toms River, New Jersey, 08753, United States

Location

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

Mentor, Ohio, 44060, United States

Location

Related Links

MeSH Terms

Interventions

Lipectomy

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsBariatric SurgeryBariatricsObesity ManagementSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Onelio Garcia, MD, F.A.C.S

    Plastic Surgery Center of South Florida

    PRINCIPAL INVESTIGATOR

  • Michael Nagy, MD, F.A.C.S

    Personal Enhancement Center

    PRINCIPAL INVESTIGATOR

  • Paul F Vanek, MD, F.A.C.S.

    Lake Hospital Systems

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 4, 2008

First Posted

August 11, 2008

Study Start

July 1, 2007

Primary Completion

September 1, 2008

Study Completion

April 1, 2009

Last Updated

June 8, 2011

Record last verified: 2011-06

Locations

US(3)