HealthyPhase 4Contra-LateralNCT00731354
VASER-Assisted Lipoplasty Compared With Suction-Assisted Lipoplasty
A Phase 4 study testing Suction-assisted Lipoplasty and VASER-assisted lipoplasty in people with Healthy, run by Sound Surgical Technologies, LLC. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Suction-assisted Lipoplasty and VASER-assisted lipoplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2007to Apr 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Paul F. Vanek, M.D., F.A.C.S.
Mentor, Ohio, 44060
Plastic Surgery Center of South Florida
Miami, Florida, 33146
Personal Enhancement Center
Toms River, New Jersey, 08753
About this study
Official title: A Multi-Center, Prospective, Randomized, Single-Blind, Controlled Clinical Trial Comparing VASER-Assisted Lipoplasty and Suction-Assisted Lipoplasty.
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.
- Conditions
- Healthy
- Being tested
- Suction-assisted Lipoplasty, VASER-assisted lipoplasty
- Keywords
- lipoplasty, liposuction, VASER, body contouring, body sculpting, Any patient, expressing, interest, in elective surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suction-assisted LipoplastyDevice
Also called Suction-assisted lipoplasty, Liposuction
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
VASER-assisted lipoplastyDevice
Also called VAL, VASER, LipoSelection, 3rd Generation UAL
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
| Study group | Role | What they receive |
|---|---|---|
| SAL | Active comparator | Each patient will have Suction Assisted Lipoplasty procedure on one side of the body (this will be considered the control side) Receives: 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. Receives: Device: VASER-assisted lipoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigators aim to assess outcomes associated with the two different methods to determine if one technology/technique offers superior results compared to the other.
Measured: 6 months
Secondary outcomes (8)
To assess the difference in patients' post-operative pain level between the SAL side and the VAL side
Measured: 6 months
To assess the difference in patients' post-operative sensation level between the SAL side and the VAL side
Measured: 6 months
To assess the difference in post-operative patient preference between the SAL side and the VAL side
Measured: 6 months
To assess the difference in post-operative ecchymosis between the SAL side and the VAL side
Measured: 6 months
To assess the difference in post-operative skin retraction between the SAL side and the VAL side
Measured: 6 months
To assess the difference in the amount of aspirate blood content between the SAL side and the VAL side
Measured: 1 day
To assess any difference in the amount or degree of complications using the the SAL procedure versus the VAL procedure
Measured: 6 months
To assess the difference in the time required for the SAL procedure versus the time required for the VAL procedure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startJul 2007
- Primary completionSep 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sound Surgical Technologies, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Onelio Garcia, MD, F.A.C.S, Principal investigator, Plastic Surgery Center of South FloridaMichael Nagy, MD, F.A.C.S, Principal investigator, Personal Enhancement CenterPaul F Vanek, MD, F.A.C.S., Principal investigator, Lake Hospital Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731354
- Sponsor's protocol ID
- SST40.2
- Acronym
- Contra-Lateral
- Status last verified
- Jun 2011
- First submitted
- 4 Aug 2008
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective, Randomized, Single-Blind, Controlled Clinical Trial Comparing VASER-Assisted Lipoplasty and Suction-Assisted Lipoplasty.
- ClinicalTrials.gov ID
- NCT00731354
- Acronym / sponsor ID
- Contra-Lateral / SST40.2
- Conditions
- Healthy
- Keywords
- lipoplasty, liposuction, VASER, body contouring, body sculpting, Any patient, expressing, interest
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Sound Surgical Technologies, LLC.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAL | Active comparator | Device: Suction-assisted LipoplastyEach patient will have Suction Assisted Lipoplasty procedure on one side of the body (this will be considered the control side) |
| VAL | Active comparator | Device: VASER-assisted lipoplastyEach patient will have VASER- assisted lipoplasty on the opposite side of the body. This will be the comparison side. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suction-assisted LipoplastyAlso: Suction-assisted lipoplasty, LiposuctionStandard 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 | Device | SAL |
| VASER-assisted lipoplastyAlso: VAL, VASER, LipoSelection, 3rd Generation UALVASER-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 | Device | VAL |
Primary outcome
Investigators aim to assess outcomes associated with the two different methods to determine if one technology/technique offers superior results compared to the other.
Time frame: 6 months
8 secondary outcomes
To assess the difference in patients' post-operative pain level between the SAL side and the VAL side
Time frame: 6 months
To assess the difference in patients' post-operative sensation level between the SAL side and the VAL side
Time frame: 6 months
To assess the difference in post-operative patient preference between the SAL side and the VAL side
Time frame: 6 months
To assess the difference in post-operative ecchymosis between the SAL side and the VAL side
Time frame: 6 months
To assess the difference in post-operative skin retraction between the SAL side and the VAL side
Time frame: 6 months
To assess the difference in the amount of aspirate blood content between the SAL side and the VAL side
Time frame: 1 day
To assess any difference in the amount or degree of complications using the the SAL procedure versus the VAL procedure
Time frame: 6 months
To assess the difference in the time required for the SAL procedure versus the time required for the VAL procedure.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
- Sound Surgical Technology - technique descriptionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Onelio Garcia, MD, F.A.C.S principal investigator
Plastic Surgery Center of South Florida
Michael Nagy, MD, F.A.C.S principal investigator
Personal Enhancement Center
Paul F Vanek, MD, F.A.C.S. principal investigator
Lake Hospital Systems
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suction-assisted Lipoplasty and VASER-assisted lipoplasty in people with Healthy, run by Sound Surgical Technologies, LLC. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigators aim to assess outcomes associated with the two different methods to determine if one technology/technique offers superior results compared to the other. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.