Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Device for Non-Invasive Abdominal Fat Reduction

NCT02700152 | Unknown

• 1 other identifier: DHF18531
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the UltraShape treatment for non-invasive abdominal fat reduction. Study subjects will undergo UltraShape treatments on the abdominal area

Conditions

Excess Abdominal Fat

Outcome Measures

Primary Outcomes (1)

• Abdominal fat thickness Reduction

  Abdominal fat thickness Reduction post UltraShape treatments at 12 weeks follow-up (12wk FU) versus baseline

  16 weeks

Secondary Outcomes (7)

• Evaluate the safety of the treatment

  day 0 until 16 weeks

• Abdominal fat thickness reduction as measured by Ultrasound

  8wk , 12wk , and 16wk

• Abdominal fat thickness reduction as measured by caliper

  8wk , 12wk , and 16wk

• Abdominal circumference reduction

  2 weeks , 4 weeks, 8wk , 12wk , and 16wk

• Investigator satisfaction:

  8wk , 12wk , and 16wk

Study Arms (1)

all subjects

EXPERIMENTAL

Eligible subjects will receive 3 treatments, 2 weeks interval, with the UltraShape device according to the study protocol and user manual. The subject will return for 3 follow up visits: four weeks (4wk FU), eight weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment, for total expected study duration of 16 weeks

Device: UltraShape

Interventions

UltraShape DEVICE

Tissue selectivity is achieved by a proprietary knowledge of ultrasound 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

all subjects

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 enrollment
• 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 between 22 to 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 or 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 above 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 (2)

Skin Care Physicians

Chestnut Hill, Massachusetts, 02467, United States

COMPLETED

Zel Skin & Laser Specialists

Edina, Minnesota, 55402, United States

RECRUITING

Related Publications (2)

• Hexsel D, Serra M, Mazzuco R, Dal'Forno T, Zechmeister D. Phosphatidylcholine in the treatment of localized fat. J Drugs Dermatol. 2003 Oct;2(5):511-8.

  PMID: 14558399 BACKGROUND

• Weinstein Velez M, Ibrahim O, Petrell K, Dover JS. Nonthermal Pulsed Ultrasound Treatment for the Reduction in Abdominal Fat: A Pilot Study. J Clin Aesthet Dermatol. 2018 Sep;11(9):32-36. Epub 2018 Sep 1.

  PMID: 30319729 DERIVED

Study Officials

• Jeffrey S Dover, M.D.

  SkinCare Physicians

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey S Dover, M.D

CONTACT

(617) 731-1600

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 7, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: November 1, 2020
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

US (2)