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History of Changes for Study: NCT03430245
VelaShape III & UltraShape Power for Thigh Circumference Reduction
Latest version (submitted December 30, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 9, 2018 None (earliest Version on record)
2 August 22, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
3 March 7, 2019 Study Status
4 December 10, 2019 Recruitment Status, Study Status, Outcome Measures, Results, Arms and Interventions and Study Design
5 December 30, 2019 Baseline Characteristics, IPDSharing and Study Status
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Study NCT03430245
Submitted Date:  February 9, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: DHF24451
Brief Title: VelaShape III & UltraShape Power for Thigh Circumference Reduction
Official Title: Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for Thigh Circumference Reduction
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2018
Overall Status: Recruiting
Study Start: January 15, 2018
Primary Completion: January 15, 2019 [Anticipated]
Study Completion: January 15, 2019 [Anticipated]
First Submitted: January 24, 2018
First Submitted that
Met QC Criteria:
February 9, 2018
First Posted: February 12, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
February 9, 2018
Last Update Posted: February 12, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Syneron Medical
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
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.
Detailed Description:

Eligible subjects will receive 3 bi-weekly treatments to the thighs at 2-week intervals, with the VelaShape III and UltraShape Power devices according to the study protocol.

Each subject will return for 3 follow up visits: four weeks (4wk FU), 8 weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment (Tx.3), for total expected study duration of 16 weeks.

Open or close this module Conditions
Conditions: Circumference Reduction
Keywords: Circumference reduction
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: VelaShape III & UltraShape Power
VelaShape III treatment with radiofrequency, infrared and massage combined with UltraShape Power treatment, using pulsed, focused ultrasound treatment.
Device: VelaShape III

The VelaShape III, the newest generation VelaShape, is a device based on the CE-cleared VelaShape II and FDA-cleared Transcend device (K120510). All devices combine controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum. The VelaShape III device is indicated for relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs and abdomen circumference.

The VelaShape III device has 150W RF energy.

Device: UltraShape Power
The newest generation UltraShape device, UltraShape Power, includes a small transducer (U-Sculpt Power), and is FDA-cleared (K170370) for lipolysis (breakdown of fat) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference and fat reduction in the flanks and thighs.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Circumference reduction in the thighs at the 12-week follow-up compared to baseline measurements
[ Time Frame: At 12 weeks after the third treatment (week 16) for each subject ]

Circumference reduction post combined VelaShape III and UltraShape Power treatments
Secondary Outcome Measures:
1. Circumference reduction in the thighs after each treatment and at follow-ups compared to baseline
[ Time Frame: At 2, 4, 8, 12 and 16 weeks for each subject ]

Circumference reduction post combined VelaShape III and UltraShape Power treatments
2. Investigator satisfaction
[ Time Frame: At 8, 12 and 16 weeks for each subject ]

Investigator satisfaction assessment will be performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very dissatisfied
3. Subject satisfaction
[ Time Frame: At 8, 12 and 16 weeks for each subject ]

Subject satisfaction assessment will be performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very dissatisfied
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  1. Signed informed consent to participate in the study.
  2. Female and male subjects, 18 and 60 years of age at the time of enrollment.
  3. Fitzpatrick Skin Type I to VI.
  4. Fat thickness of at least 1.5 cm (measured by calibrated caliper).
  5. BMI interval: 22 ≤ BMI ≤ 30 (normal to overweight, but not obese).
  6. 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).
  7. 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).
  8. General good health confirmed by medical history and skin examination of the treated area.
  9. Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
  10. Willingness to refrain from a change in diet/ exercise/medication regimen for the entire course of the study.
  11. Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.

Exclusion Criteria:

  1. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism.
  2. Known hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease.
  3. 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.
  4. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
  5. Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone.
  6. Having undergone any other surgery in the treated areas within 12 months of treatment or during the study, including liposuction.
  7. Previous body contouring procedures in the treatment area within 12 months.
  8. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing.
  9. Known photosensitivity.
  10. 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.
  11. 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.
  12. Very poor skin quality (i.e., severe laxity).
  13. Abdominal wall diastasis or hernia on physical examination.
  14. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months.
  15. Obesity (BMI > 30).
  16. Pregnant, childbirth within the last 12 months or breastfeeding women.
  17. Any acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study.
  18. Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six months).
  19. Inability to comply with circumference measurement procedure (e.g., inability to hold breath for the required duration).
  20. Abdominal fat thickness lower than 2.5 cm after strapping.
  21. Participation in another clinical study within the last 6 months.
  22. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Open or close this module Contacts/Locations
Central Contact Person: Shlomit Mann, MA
Telephone: (972) 547 800 268
Email: shlomitm@syneron-candela.com
Locations: United States, New Jersey
Skin Laser & Surgery Specialist of NY/NJ
[Recruiting]
Hackensack, New Jersey, United States, 07601
Contact:Contact: Amy Tank, PA 201-441-9890 amypa@skinandlasers.rsidev.net
Contact:Principal Investigator: David Goldberg, MD
Contact:Sub-Investigator: Amy Tank, PA
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations: 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. PubMed 28009680
Links:
Available IPD/Information:
Open or close this module Document Section
Study Protocol and Statistical Analysis Plan
Document Date: October 6, 2017
Uploaded: 02/05/2018 16:39
File Name: Prot_SAP_000.pdf

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