Non-Invasive Abdominal Fat Reduction With BMI Above 28

NCT02711618 | Unknown

• 1 other identifier: DHF19571
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 3

Brief Summary

Prospective, one arm, baseline-controlled clinical study for the evaluation of UltraShape contour I V3 for non-invasive fat reduction. The study will conduct using the UltraShape contour I V3 using U-Sculpt/VDF transducer on the abdomen.

Conditions

Unwanted Fat

Outcome Measures

Primary Outcomes (1)

• Change in abdominal fat thickness compared to baseline

  Abdominal fat thickness reduction post UltraShape contour I V3 treatments at 12 weeks follow-up (12wk FU) versus baseline.

  Baseline and 12 weeks

Secondary Outcomes (7)

• Change in abdominal fat thickness compared to baseline

  Baseline, 8 weeks and 16 weeks

• Change in abdominal fat thickness compared to baseline

  Baseline, 8 weeks, 12 weeks, and 16 weeks

• Change in abdominal circumference reduction compared to baseline

  Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

• Blood panel and fat lipid profile compared to baseline levels

  Baseline, 4 weeks and 16 weeks

• Investigator satisfaction

  8 weeks, 12 weeks, and 16 weeks

Other Outcomes (1)

• Number of participants with adverse events

  day 0 until 16 weeks

Study Arms (1)

UltraShape Contour I V3 treatment

EXPERIMENTAL

Up to 60 healthy adult volunteers seeking noninvasive fat reduction, male and females at up to four sites, age of 18 to 60, with BMI above 28

Device: UltraShape Contour I V3

Interventions

UltraShape Contour I V3 DEVICE

Tissue selectivity is achieved by a proprietary knowledge of parameters ensuring specific destruction of the fat cells only within the target area. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time

Also known as: Contour I V3

UltraShape Contour I V3 treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent to participate in the study.
• Female and male subjects,18 and 60 years of age at the time of enrolment
• Fitzpatrick Skin Type I to VI.
• Abdominal fat thickness of at least 1.5 cm (measured by calibrated caliper).
• BMI above 28 (normal to overweight).
• If female, not pregnant, lactating and 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).
• Negative urine pregnancy test as tested before the first treatment for women with bearing potential (e.g. not menopause). In addition, negative pregnancy following pregnancy inquiry for each visit (treatments and follow up), starting from the second treatment.
• General good health confirmed by medical history and skin examination of the treated area.
• Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
• Willingness to refrain from a change in diet/ exercise/medication regimen for the entire course of the study.
• Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations

You may not qualify if:

• History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
• Current hyperlipidemia, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease or malignancy
• Previous liposuction or body contouring procedures in the treatment areas of the abdomen or flanks. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing.
• 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.
• Poor skin quality (i.e., laxity).
• Abdominal wall diastasis or hernia on physical examination.
• Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months.
• 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.
• Unstable weight within the last 6 months (i.e., ± 3 percent weight change in the prior six months).
• Inability to comply with circumference measurement procedure (e.g., inability to hold breath for the required duration).
• Abdominal fat thickness lower than 2.5 cm after strapping.
• Participation in another clinical study within the last 6 months.
• Non-invasive body-contouring procedures in the treatment area completed less than twelve months prior to study enrollment.
• As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (3)

Sanctuary Plastic Surgery

Boca Raton, Florida, 33431, United States

Location

833 Northern Boulevard

Great Neck, New York, 11021, United States

Location

Laser and Skin Surgery Center

New York, New York, 10016, United States

Location

Related Publications (1)

• Arner P. Regional adipocity in man. J Endocrinol. 1997 Nov;155(2):191-2. doi: 10.1677/joe.0.1550191. No abstract available.

  PMID: 9415044 BACKGROUND

Study Officials

• Alan H Gold, M.D.

  Aesthetic Plastic Surgery & Cosmetic Medicine Great Neck, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 17, 2016
• Study Start: October 29, 2015
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2017
• Last Updated: April 6, 2017

Record last verified: 2017-04

Locations

US (3)