ClinicalTrials.gg
Sign In
CompletedNCT03430245Updated Jan 9, 2020Results posted

VelaShape III & UltraShape Power for Thigh Circumference Reduction

An interventional study of VelaShape III and UltraShape Power in Circumference Reduction, sponsored by Syneron Medical. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-09.

Sponsored by Syneron Medical · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Circumference Reduction

Keywords

  • Circumference reduction
03

In context

Lead sponsor

Syneron Medical is the lead sponsor of 41 studies on the registry; none are open to participants now.

Browse Candela studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed 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. interval: 22 ≤ BMI ≤ 30 (normal to overweight, but not obese).
  6. Female subjects must be either , surgically sterilized, or using a medically acceptable form of 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 (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

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, positive status, blood coagulopathy or excessive bleeding, 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 ( > 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • 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 · Device: UltraShape Power

Interventions

  • DeviceVelaShape III

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

  • DeviceUltraShape Power

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

06

What researchers measure

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.

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

Secondary outcomes

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

    The thighs circumference change (at midline) after combined treatment with VelaShape III and UltraShape Power treatments compared to baseline. The changed of thighs circumference was calculated at 2, 4, 8 and 12 weeks after baseline (which are second treatment , third treatment, 4 and 8 week follow-up visits, respectively). Negative change represent reduction in thigh circumference.

    Time frame: At 2, 4, 8 and 12 weeks after baseline

  2. Investigator Satisfaction

    Investigator satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (4, 8 and 12 weeks after the last treatment)

    Time frame: At 4, 8 and 12 weeks follow-up visits

  3. Subject Satisfaction

    Subject satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (at 4, 8 and 12 weeks after the last treatment visit).

    Time frame: At 4, 8 and 12 week follow-up visits

07

Results

Posted Dec 26, 2019
Limitations and caveats
Small number of subjects analyzed.

Participant flow

Participant flow — Overall Study
MilestoneVelaShape III & UltraShape Power
Started16
Completed9
Not completed7
Withdrew: Withdrawal by subject6
Withdrew: Lost to follow-up1

Outcome measures

PrimaryCircumference 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.

Time frame:
At 12 weeks after the third treatment (week 16) for each subject
Reported as:
Mean · centimeter
Circumference Change in the Thighs at the 12-week Follow-up Compared to Baseline Measurements
centimeterVelaShape III & UltraShape Power
Circumference Change in the Thighs at the 12-week Follow-up Compared to Baseline Measurements-2.8 ± 1.8
SecondaryChange in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits

The thighs circumference change (at midline) after combined treatment with VelaShape III and UltraShape Power treatments compared to baseline. The changed of thighs circumference was calculated at 2, 4, 8 and 12 weeks after baseline (which are second treatment , third treatment, 4 and 8 week follow-up visits, respectively). Negative change represent reduction in thigh circumference.

Time frame:
At 2, 4, 8 and 12 weeks after baseline
Reported as:
Mean · centimeter
Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits
centimeterVelaShape III & UltraShape Power
Circumference change at the second treatment-0.4 ± 0.6
Circumference change at the third treatment-0.8 ± 0.7
Circumference change at 8 weeks after baseline-1.8 ± 0.8
Circumference change at 12 weeks after baseline-2.2 ± 1.6
SecondaryInvestigator Satisfaction

Investigator satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (4, 8 and 12 weeks after the last treatment)

Time frame:
At 4, 8 and 12 weeks follow-up visits
Reported as:
Count of participants · Participants
Investigator Satisfaction
ParticipantsVelaShape III & UltraShape Power
Investigator satisfaction at 4 week follow-up — (-2) Very unsatisfied0
Investigator satisfaction at 4 week follow-up — (-1) Unsatisfied0
Investigator satisfaction at 4 week follow-up — (0) No Opinion0
Investigator satisfaction at 4 week follow-up — (1) Satisfied5
Investigator satisfaction at 4 week follow-up — (2) Very satisfied4
Investigator satisfaction at 8 week follow-up — (-2) Very unsatisfied0
Investigator satisfaction at 8 week follow-up — (-1) Unsatisfied0
Investigator satisfaction at 8 week follow-up — (0) No Opinion0
Investigator satisfaction at 8 week follow-up — (1) Satisfied4
Investigator satisfaction at 8 week follow-up — (2) Very satisfied5
Investigator satisfaction at 12 week follow-up — (-2) Very unsatisfied0
Investigator satisfaction at 12 week follow-up — (-1) Unsatisfied0
Investigator satisfaction at 12 week follow-up — (0) No Opinion0
Investigator satisfaction at 12 week follow-up — (1) Satisfied2
Investigator satisfaction at 12 week follow-up — (2) Very satisfied7
SecondarySubject Satisfaction

Subject satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (at 4, 8 and 12 weeks after the last treatment visit).

Time frame:
At 4, 8 and 12 week follow-up visits
Reported as:
Count of participants · Participants
Subject Satisfaction
ParticipantsVelaShape III & UltraShape Power
Subject satisfaction at 4 week follow-up — (-2) Very unsatisfied0
Subject satisfaction at 4 week follow-up — (-1) Unsatisfied0
Subject satisfaction at 4 week follow-up — (0) No Opinion0
Subject satisfaction at 4 week follow-up — (1) Satisfied3
Subject satisfaction at 4 week follow-up — (2) Very satisfied6
Subject satisfaction at 8 week follow-up — (-2) Very unsatisfied0
Subject satisfaction at 8 week follow-up — (-1) Unsatisfied0
Subject satisfaction at 8 week follow-up — (0) No Opinion1
Subject satisfaction at 8 week follow-up — (1) Satisfied3
Subject satisfaction at 8 week follow-up — (2) Very satisfied5
Subject satisfaction at 12 week follow-up — (-2) Very unsatisfied0
Subject satisfaction at 12 week follow-up — (-1) Unsatisfied0
Subject satisfaction at 12 week follow-up — (0) No Opinion0
Subject satisfaction at 12 week follow-up — (1) Satisfied2
Subject satisfaction at 12 week follow-up — (2) Very satisfied7

Adverse events

Collected over The period of time over which adverse event data were collected is from treatment visit until 12 weeks follow-up (16 weeks post baseline) treatment. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
VelaShape III & UltraShape Power0/16 (0%)0/16 (0%)1/16 (6.3%)
Most frequent other events
Most frequent other events
EventVelaShape III & UltraShape Power
BlisteringSkin and subcutaneous tissue disorders1/16

Baseline characteristics

Subjects treated with VelaShape III and UltraShape Power

Age, Categorical
Age, Categorical(Participants)VelaShape III & UltraShape Power
<=18 years0
Between 18 and 65 years16
>=65 years0
Age, Continuous
Age, Continuous(years)VelaShape III & UltraShape Power
Mean46.1 ± 10.6
Sex: Female, Male
Sex: Female, Male(Participants)VelaShape III & UltraShape Power
Female16
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)VelaShape III & UltraShape Power
Hispanic or Latino4
Not Hispanic or Latino12
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)VelaShape III & UltraShape Power
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White16
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)VelaShape III & UltraShape Power
United States16
Mean thigh circumference
Mean thigh circumference(centimeter)VelaShape III & UltraShape Power
Mean62.1 ± 6.0
08

Study locations

1 site
  • Skin Laser & Surgery Specialist of NY/NJ
    Hackensack, New Jersey 07601, United States
09

References and documents

Publications

  • 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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in May 2019, 15 months.

Results were first posted in Dec 2019, 6 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 24, 2018
First posted
Feb 12, 2018
StartActual
Feb 19, 2018
Primary completionActual
May 30, 2019
CompletionActual
Jul 3, 2019
Results first posted
Dec 26, 2019
Last update
Jan 9, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03430245
Lead sponsor
Syneron Medical
Responsible party
Sponsor
First posted
Feb 12, 2018
Start date
Feb 19, 2018
Primary completion
May 30, 2019
Completion
Jul 3, 2019
Results posted
Dec 26, 2019
Last update
Jan 9, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Syneron Medical →

Start the discussion