Ultrashape System in Combination With VelaShape II Device for Circumferential Reduction

NCT02154113 | Completed

• 1 other identifier: US-CA 02
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the clinical performance of the Ultrashape system with VelaShape II device for reduction of the waist.

Conditions

Abdominal Fat

Keywords

Syneron; Velashape; ELOS; Ultrashape

Outcome Measures

Primary Outcomes (1)

• Difference in circumference reduction between baseline and follow-up visits

  The primary efficacy endpoint in this trial is the statistical difference in circumference reduction between Control (baseline measurement, Vist 2 / Day 0) and two points of follow-up measurement: 2 weeks (Visit 5 / Day 42) and 12 weeks (Visit 8 / Day 112) following the last Tx session. The following procedure will be used to compute the Circumference Difference primary endpoint:

  Base line, 2 and 12 weeks post last treatment

Secondary Outcomes (1)

• Adverse Events

  The duration of the study, an expected average of 5 months.

Other Outcomes (1)

• Subject Satisfaction Scores

  2, 4, 6, 8,10 and 12 week in a study.

Study Arms (2)

Velashape II device

ACTIVE COMPARATOR

Controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation.

Device: Velashape II

Ultrashape

ACTIVE COMPARATOR

The UltraShape Contour I V3 uses focused ultrasound to produce localized mechanical motion within fat tissues and cells for the purpose of producing mechanical cellular membrane disruption.

Device: Ultrashape

Interventions

Ultrashape DEVICE

All subjects receive 3 successive Ultrashape treatments every two weeks in the anterior abdomen.

Ultrashape

Velashape II DEVICE

All subjects receive 3 successive Velashape treatments every two weeks in the anterior abdomen.

Also known as: Vela, Velashape

Velashape II device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fat thickness of at least 1.5 cm in the anterior abdominal and flanks prior to initial treatment (measurement by caliper)
• For women of child-bearing potential: negative pregnancy test in the 24 hour period prior to enrollment and 24 hour period prior to each treatment or FU visit (measured in urine)
• General good health confirmed by medical history and skin examination of the treated area
• Written informed consent to participate in the study
• Ability to comply with the requirements of the study
• BMI≤ 30

You may not qualify if:

• History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
• Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease or malignancy
• Previous liposuction in the treatment areas
• 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
• Obesity (BMI \> 30)
• Childbirth within the last 12 months or women who suckling a child
• 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% weight change in the prior six months)
• Inability to comply with circumference measurement procedure (e.g., inability to held breath for the required duration)
• Participation in another clinical study
• Previous body contouring treatments in the treatment areas

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (2)

BC Laser & SkinCare Clinic

Surrey, British Columbia, V3T 1W7, Canada

Location

Cosmedica

Pointe-Claire, Quebec, H9R 5N3, Canada

Location

Study Officials

• Shlomit Mann

  Syneron Medical Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: June 3, 2014
• Study Start: October 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 3, 2014

Record last verified: 2014-05

Locations

CA (2)