Clinical trial NCT00731354: VASER-Assisted Lipoplasty Compared With Suction-Assisted Lipoplasty
Official title: A Multi-Center, Prospective, Randomized, Single-Blind, Controlled Clinical Trial Comparing VASER-Assisted Lipoplasty and Suction-Assisted Lipoplasty.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: lipoplasty
liposuction
VASER
body contouring
body sculpting
Any patient
expressing
interest
in elective surgery
Lead sponsor: Sound Surgical Technologies, LLC.
Sponsor class: INDUSTRY
First posted: 2008-08-11
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 6 months
Secondary outcomes:
measure: To assess the difference in patients' post-operative pain level between the SAL side and the VAL side
timeFrame: 6 months
measure: To assess the difference in patients' post-operative sensation level between the SAL side and the VAL side
timeFrame: 6 months
measure: To assess the difference in post-operative patient preference between the SAL side and the VAL side
timeFrame: 6 months
measure: To assess the difference in post-operative ecchymosis between the SAL side and the VAL side
timeFrame: 6 months
measure: To assess the difference in post-operative skin retraction between the SAL side and the VAL side
timeFrame: 6 months
measure: To assess the difference in the amount of aspirate blood content between the SAL side and the VAL side
timeFrame: 1 day
measure: To assess any difference in the amount or degree of complications using the the SAL procedure versus the VAL procedure
timeFrame: 6 months
measure: To assess the difference in the time required for the SAL procedure versus the time required for the VAL procedure.
timeFrame: 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Plastic Surgery Center of South Florida
state: Florida
city: Toms River
country: United States
facility: Personal Enhancement Center
state: New Jersey
city: Mentor
country: United States
facility: Paul F. Vanek, M.D., F.A.C.S.
state: Ohio
Study officials:
affiliation: Plastic Surgery Center of South Florida
name: Onelio Garcia, MD, F.A.C.S
role: PRINCIPAL_INVESTIGATOR
affiliation: Personal Enhancement Center
name: Michael Nagy, MD, F.A.C.S
role: PRINCIPAL_INVESTIGATOR
affiliation: Lake Hospital Systems
name: Paul F Vanek, MD, F.A.C.S.
role: PRINCIPAL_INVESTIGATOR
References: