VelaShape III & UltraShape Power for Thigh Circumference Reduction

NCT03430245 | Completed Results FDA Device

• 1 other identifier: DHF24451
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, one-arm, baseline-controlled pilot study for the evaluation of the VelaShape III combined with UltraShape Power treatment for non-invasive circumference reduction to the thighs.

Conditions

Circumference Reduction

Keywords

Circumference reduction

Outcome Measures

Primary Outcomes (1)

• Circumference Change in the Thighs at the 12-week Follow-up Compared to Baseline Measurements

  Circumference change of thigh midline post combined VelaShape III and UltraShape Power treatments. Negative change represent reduction in thigh circumference.

  At 12 weeks after the third treatment (week 16) for each subject

Secondary Outcomes (3)

• Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits

  At 2, 4, 8 and 12 weeks after baseline

• Investigator Satisfaction

  At 4, 8 and 12 weeks follow-up visits

• Subject Satisfaction

  At 4, 8 and 12 week follow-up visits

Study Arms (1)

VelaShape III & UltraShape Power

EXPERIMENTAL

VelaShape III treatment with radiofrequency, infrared and massage combined with UltraShape Power treatment, using pulsed, focused ultrasound treatment.

Device: VelaShape III; Device: UltraShape Power

Interventions

VelaShape III DEVICE

The VelaShape III device combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum.

VelaShape III & UltraShape Power

UltraShape Power DEVICE

The UltraShape Power device uses focused ultrasound energy for lipolysis (breakdown of fat) via a non-thermal mechanism of action.

VelaShape III & UltraShape Power

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 (measured by calibrated caliper).
• BMI interval: 22 ≤ BMI ≤ 30 (normal to overweight, but not obese).
• Female subjects 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 visit for women with child-bearing potential (e.g. not menopausal).
• 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.
• Known photosensitivity.
• 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 \> 30).

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (1)

Skin Laser & Surgery Specialist of NY/NJ

Hackensack, New Jersey, 07601, United States

Location

Related Publications (1)

• Coleman WP 3rd, Coleman W 4th, Weiss RA, Kenkel JM, Ad-El DD, Amir R. A Multicenter Controlled Study to Evaluate Multiple Treatments With Nonthermal Focused Ultrasound for Noninvasive Fat Reduction. Dermatol Surg. 2017 Jan;43(1):50-57. doi: 10.1097/DSS.0000000000000918.

  PMID: 28009680 BACKGROUND

Limitations and Caveats

Small number of subjects analyzed.

Results Point of Contact

• Title: Director of Clinical Marketing
• Organization: Candela Corporation

doranr@candelamedical.com

+1 949.246.7983

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: January 24, 2018
• First Posted: February 12, 2018
• Study Start: February 19, 2018
• Primary Completion: May 30, 2019
• Study Completion: July 3, 2019
• Last Updated: January 9, 2020
• Results First Posted: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)