UltraShape Device for Thigh Fat and Circumference Reduction vs. Control

NCT02488083 | Unknown

• 1 other identifier: DHF17991
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

UltraShape Device for Thigh Fat and Circumference Reduction: Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the UltraShape treatment for non-invasive fat and circumference reduction.

Conditions

Unwanted Thigh Fat

Keywords

non-invasive

Outcome Measures

Primary Outcomes (1)

• evaluate the efficacy of the UltraShape device by evaluating the non-invasive fat and circumference reduction

  8 weeks up to 20 weeks

Secondary Outcomes (7)

• safety issues assessed by The number, severity and type of any adverse event recorded throughout the study and post treatment (immediate and delayed response)

  day 0 up to 20 weeks

• thigh circumference reduction

  four weeks (4wk FU), eight weeks (8wk FU) and 16 weeks (16wk FU) after the last treatment,

• thigh fat thickness reduction by ultrasound

  day 0, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 20 weeks

• thigh fat thickness reduction by caliper

  day 0, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 20 weeks

• Subject satisfaction by questionnaire

  8 weeks, 12 weeks, 20 weeks

Study Arms (1)

all subjects treated by UltraShape

EXPERIMENTAL

all the patients undergo fat reduction treatment by UltraShape

Device: Ultrashape

Interventions

Ultrashape DEVICE

circumference reduction

Also known as: fat reduction

all subjects treated by UltraShape

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.
• Fat thickness of at least 1.5 cm in the treated area (measured by calibrated caliper).
• BMI interval: BMI in range of 22- 30 (normal to overweight, but not obese).
• 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).
• 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).
• 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
• Known hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
• 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
• Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
• Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone
• Having undergone any other surgery in the treated areas within 12 months of treatment or during the study, including liposuction
• Previous body contouring procedures in the treatment area within 12 months
• History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
• 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
• 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
• Very poor skin quality (i.e., severe 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
• Obesity (BMI bigger than 30)
• 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

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (3)

Coleman Center for Cosmetic Dermatologic Surgery

Metairie, Louisiana, 70006, United States

RECRUITING

Maryland Laser, Skin, & Vein Institute

Baltimore, Maryland, 21030, United States

RECRUITING

Skin Laser & Surgery Specialist of NY/NJ

Hackensack, New Jersey, 07601, United States

COMPLETED

Related Publications (2)

• Ascher B. Safety and efficacy of UltraShape Contour I treatments to improve the appearance of body contours: multiple treatments in shorter intervals. Aesthet Surg J. 2010 Mar;30(2):217-24. doi: 10.1177/1090820X09360692.

  PMID: 20442099 BACKGROUND

• Teitelbaum SA, Burns JL, Kubota J, Matsuda H, Otto MJ, Shirakabe Y, Suzuki Y, Brown SA. Noninvasive body contouring by focused ultrasound: safety and efficacy of the Contour I device in a multicenter, controlled, clinical study. Plast Reconstr Surg. 2007 Sep;120(3):779-789. doi: 10.1097/01.prs.0000270840.98133.c8.

  PMID: 17700131 BACKGROUND

Study Officials

• Robert Weiss, MD

  Maryland Laser Skin and Vein Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Weiss, MD

CONTACT

410-666-3960

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: May 26, 2015
• First Posted: July 2, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

US (3)