Recruiting

Fat Reduction vs. Control

Sponsor:

Syneron Medical

Code:

NCT02465775

Conditions

Flanks Fat Reduction vs. Control

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

UltraShape treatment

Study Details

Brief summary:

Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation the performance of the UltraShape treatment for non-invasive fat reduction by compare control and treated flanks.

Study subjects will undergo UltraShape treatments on one randomized flank using the U-Sculpt/VDF Transducer. The second flank will not be treated (control). Both flanks (treated and control) will be compared to baseline, as well as, one to each other

Conditions

Flanks Fat Reduction vs. Control

Study ID

NCT02465775

Start date

Jul, 2015

Status verified date

Apr, 2016

Completion date

Dec, 2017

Anticipated

Primary completion date

Sep, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Signed informed consent to participate in the study.
2. Female and male subjects, between 18 to 60 years of age at the time of enrolment
3. Fitzpatrick Skin Type I to VI.
4. Fat thickness of at least 1.5 cm in the treated area (measured by calibrated caliper).
5. BMI interval: BMI between 22 to 30 (normal to overweight, but not obese).
6. If female, not pregnant or lactating, must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence).
7. In addition, negative urine pregnancy test as tested before each treatment and at the last follow-up visit for women with child-bearing potential (e.g. not menopause).
8. General good health confirmed by medical history and skin examination of the treated area.
9. Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
10. Willingness to refrain from a change in diet/ exercise/medication regimen for the entire course of the study.
11. Willing to have photographs and images taken of the treated areas to be used, de-identified in evaluations, publications and presentations

Exclusion Criteria:

1. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
2. Known hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
3. Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions
4. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
5. Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone
6. Having undergone any other surgery in the treated areas within 12 months of treatment or during the study, including liposuction
7. Previous body contouring procedures in the treatment area within 12 months
8. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
9. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course
10. Skin lesions in the treatment area other than simple nevi on physical examination (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment area
11. Very poor skin quality (i.e., severe laxity)
12. Abdominal wall diastasis or hernia on physical examination
13. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
14. Obesity (BMI above 30)
15. Childbirth within the last 12 months or breastfeeding women. Any acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study
16. Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six months)
17. Fat thickness lower than 2.5 cm after strapping at the treated area.
18. Participation in another clinical study involving same anatomical areas within the last 6 months (or 30 days in case different anatomical areas were treated in previous trial/s).
19. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: UltraShape treatment in all subjects

UltraShape treatment for fat reduction to unilateral flank for all subjects with untreated flank as control.

Interventions

UltraShape treatment

Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.

Primary outcome measure

  • efficacy of flank fat reduction vs. control [ Time Frame: up to 16 weeks after treatment ]

Central Contacts and Locations

Central contacts

Robert Weiss, MD

410-666-3960

Locations

Coleman Center for Cosmetic Dermatologic Surgery

Recruiting

Metairie, Louisiana, United States, 70006

Contacts

Principal Investigator:

William P Coleman, M.D.

Maryland Laser, Skin, & Vein Institute, LLC

Recruiting

Hunt Valley, Maryland, United States, 21030

Contacts

Principal Investigator:

Robert A Weiss, M.D.

Gold Skincare

Recruiting

Nashville, Tennessee, United States, 37215

Contacts

Principal Investigator:

Michael Gold, MD

More Information

Sponsor

Syneron Medical

Last update posted

Apr 14, 2016

Last verified

Apr, 2016

Keywords

  • non-invasive

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Syneron Medical on 2016-04-14.