Excess Abdominal FatNCT02748928
UltraShape Power for Abdominal Fat and Circumference Reduction
A study testing UltraShape Power in people with Excess Abdominal Fat, run by Syneron Medical at 8 sites in United States.
Trial summary
Prospective, one arm, baseline-controlled, clinical study for the evaluation of the UltraShape Power treatment using the U-Sculpt Power Transducer for non-invasive abdominal fat and circumference reduction. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Excess Abdominal Fat
- What is being tested?
- UltraShape Power
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 8 sitesUnited States
- Study dates
- 8 Jun 2016to 23 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A subject is eligible to participate in the study if he/she meets all the following inclusion criteria:
- 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).
- Body mass index (BMI): BMI between 22 to 30 (normal to overweight, but not obese).
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- 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.
Who cannot join
- A subject is not eligible for participation in this study if he or she meets any of the following exclusion criteria:
- 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
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- 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
- Unstable weight within the last 6 months (i.e., ± 3 percent weight change in the prior six months)
- Inability to comply with circumference measurement procedure (e.g., inability to hold breath for the required duration)
- Fat thickness lower than 2.5 cm after strapping at the treated area.
- Participation in another clinical study involving same anatomical areas within the last 6 months (or 30 days in case different anatomical areas were treated in previous trials)
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Jewell Plastic Surgery
Eugene, Oregon, 97401
Prana Medical Aesthetics
Jacksonville Beach, Florida, 32250
A Womans Touch Plastic Surgery
Louisville, Kentucky, 40205
Baumann Cosmetic and Research Institute, Inc
Miami, Florida, 33137
DuPage Medical Group
Naperville, Illinois, 60563
Union Square Laser Dermatology
New York, New York, 10003
Laser Skin Surgery Center of Northern California
Sacramento, California, 95816
Syneron Candela Institute for Education Clinic
Wayland, Massachusetts, 01778
About this study
Official title: Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction
Prospective, one arm, baseline-controlled, clinical study for the evaluation of the UltraShape Power treatment using the U-Sculpt Power Transducer for non-invasive abdominal fat and circumference reduction.
Read the detailed description
Up to 120 healthy adult volunteers, seeking noninvasive abdominal fat and circumference reduction, male and females, 18 to 60 years of age from 6 investigational sites. Eligible subjects will receive 3 bi-weekly treatments (2 weeks interval) with the UltraShape Power device utilizing the U-Sculpt Power Transducer according to the study protocol. Subjects will return for 3 follow-up visits: four weeks (4wk FU), eight weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment (Third Treatment).
Each subject will be enrolled for total expected study duration of 16 weeks. Subject's abdominal fat thickness and circumference will be measured at the measurements points and will be assessed at each visit. Additionally, a subject questionnaire will be completed in each follow-up visit (4wk, 8wk and 12wk FU). Finally, photography will be performed under visible light conditions of the front, right, left and back view. Most of the assessments will occur at each of the visits (all treatments and all follow-up visits) to the clinic.
- Conditions
- Excess Abdominal Fat
- Being tested
- UltraShape Power
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltraShape PowerDevice
Also called UltraShape
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
| Study group | Role | What they receive |
|---|---|---|
| UltraShape Power treatment to abdomen | Experimental | Eligible subjects will receive 3 treatments, 2 weeks interval, with the UltraShape Power 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 Receives: Device: UltraShape Power |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound
Abdominal fat thickness change post UltraShape treatments at 12 weeks follow-up (12wk FU) after final treatment versus baseline
Measured: Baseline and 16 weeks (4 weeks treatment + 12 week follow up)
Secondary outcomes (5)
Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound
Abdominal fat thickness change as measured by ultrasound post UltraShape Power treatments at 4-week, 8-week and 12-week (from baseline visit) versus baseline
Measured: Baseline and at 4, 8, and 12 weeks (from baseline visit)
Change in Abdominal Circumference Compared to Baseline
Abdominal circumference change post UltraShape Power treatments
Measured: Baseline and at 4, 8, 12 and 16 weeks (from baseline visit)
Number of Investigators Reporting Satisfaction With Participants' Treatment Outcome
Satisfaction assessment will be performed independently by the investigator using a 4-point Likert scale questionnaire from 0 = dissatisfied to 3= very satisfied.
The values in the data table reflect the number of Investigators who were "satisfied" or "very satisfied" (i.e., "reported a 2 or 3") with Participant Treatment Outcome, as assessed by the questionnaire.
Measured: 8, 12 and 16 weeks (from baseline visit)
Number of Participants Reporting Satisfaction With Treatment Outcome
Satisfaction assessment will be performed independently by the subjects using a 4-point Likert scale questionnaire from 0 = dissatisfied to 3= very satisfied.
The values in the data table reflect the number of participants who were "satisfied" or "very satisfied" (i.e., "reported a 2 or 3") with Treatment Outcome, as assessed by the questionnaire.
Measured: 8, 12 and 16 weeks (from baseline visit)
Pain Scale for Rating Discomfort Associated With Treatment
Comfort assessment will be performed independently by the subjects using a numerical scale (0-no discomfort to 10-Worst possible discomfort). The subjects will answer this questionnaire after each of the three treatments.
Measured: Day 0 (1st treatment), at 2 weeks (2nd treatment) and at 4 weeks (3rd treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start8 Jun 2016
- Primary completion15 Feb 2017
- Study completion23 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Excess Abdominal FatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruthie Amir, MD, Study director, Syneron Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748928
- Sponsor's protocol ID
- DHF21621
- Status last verified
- Mar 2019
- First submitted
- 20 Apr 2016
- Last updated
- 19 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Overall results shared with study investigators.
Publications
Ascher B. Safety and efficacy of UltraShape Contour I treatments to improve the appearance of body contours: multiple treatments in shorter intervals. Aesthet Surg J. 2010 Mar;30(2):217-24. doi: 10.1177/1090820X09360692.
PubMed 20442099Moreno-Moraga J, Valero-Altes T, Riquelme AM, Isarria-Marcosy MI, de la Torre JR. Body contouring by non-invasive transdermal focused ultrasound. Lasers Surg Med. 2007 Apr;39(4):315-23. doi: 10.1002/lsm.20478.
PubMed 17457840Chang SL, Huang YL, Lee MC, Chang CH, Lin YF, Cheng CY, Hu S. Long-term follow-up for noninvasive body contouring treatment in Asians. Lasers Med Sci. 2016 Feb;31(2):283-7. doi: 10.1007/s10103-015-1852-0. Epub 2015 Dec 29.
PubMed 26714982
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Power Device Using the U-Sculpt Power Transducer for Abdominal Fat and Circumference Reduction
- ClinicalTrials.gov ID
- NCT02748928
- Acronym / sponsor ID
- DHF21621
- Conditions
- Excess Abdominal Fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 23 Apr 2018 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Posted 7 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, one arm, baseline-controlled, clinical study for the evaluation of the UltraShape Power treatment using the U-Sculpt Power Transducer for non-invasive abdominal fat and circumference reduction.
Detailed description
Up to 120 healthy adult volunteers, seeking noninvasive abdominal fat and circumference reduction, male and females, 18 to 60 years of age from 6 investigational sites. Eligible subjects will receive 3 bi-weekly treatments (2 weeks interval) with the UltraShape Power device utilizing the U-Sculpt Power Transducer according to the study protocol. Subjects will return for 3 follow-up visits: four weeks (4wk FU), eight weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment (Third Treatment).
Each subject will be enrolled for total expected study duration of 16 weeks. Subject's abdominal fat thickness and circumference will be measured at the measurements points and will be assessed at each visit. Additionally, a subject questionnaire will be completed in each follow-up visit (4wk, 8wk and 12wk FU). Finally, photography will be performed under visible light conditions of the front, right, left and back view. Most of the assessments will occur at each of the visits (all treatments and all follow-up visits) to the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UltraShape Power treatment to abdomen | Experimental | Device: UltraShape PowerEligible subjects will receive 3 treatments, 2 weeks interval, with the UltraShape Power 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- A subject is eligible to participate in the study if he/she meets all the following inclusion criteria:
- 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).
Key exclusion criteria (21 listed)
- A subject is not eligible for participation in this study if he or she meets any of the following exclusion criteria:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltraShape PowerAlso: UltraShapeTissue 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 | Device | UltraShape Power treatment to abdomen |
Primary outcome
Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound
Time frame: Baseline and 16 weeks (4 weeks treatment + 12 week follow up)
Abdominal fat thickness change post UltraShape treatments at 12 weeks follow-up (12wk FU) after final treatment versus baseline
5 secondary outcomes
Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound
Time frame: Baseline and at 4, 8, and 12 weeks (from baseline visit)
Change in Abdominal Circumference Compared to Baseline
Time frame: Baseline and at 4, 8, 12 and 16 weeks (from baseline visit)
Number of Investigators Reporting Satisfaction With Participants' Treatment Outcome
Time frame: 8, 12 and 16 weeks (from baseline visit)
Number of Participants Reporting Satisfaction With Treatment Outcome
Time frame: 8, 12 and 16 weeks (from baseline visit)
Pain Scale for Rating Discomfort Associated With Treatment
Time frame: Day 0 (1st treatment), at 2 weeks (2nd treatment) and at 4 weeks (3rd treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20442099Ascher B. Safety and efficacy of UltraShape Contour I treatments to improve the appearance of body contours: multiple treatments in shorter intervals. Aesthet Surg J. 2010 Mar;30(2):217-24. doi: 10.1177/1090820X09360692.
- Background: PubMed 17457840Moreno-Moraga J, Valero-Altes T, Riquelme AM, Isarria-Marcosy MI, de la Torre JR. Body contouring by non-invasive transdermal focused ultrasound. Lasers Surg Med. 2007 Apr;39(4):315-23. doi: 10.1002/lsm.20478.
- Background: PubMed 26714982Chang SL, Huang YL, Lee MC, Chang CH, Lin YF, Cheng CY, Hu S. Long-term follow-up for noninvasive body contouring treatment in Asians. Lasers Med Sci. 2016 Feb;31(2):283-7. doi: 10.1007/s10103-015-1852-0. Epub 2015 Dec 29.
- Individual participant dataSharing planned: No. Overall results shared with study investigators.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruthie Amir, MD study director
Syneron Medical
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UltraShape Power in people with Excess Abdominal Fat, run by Syneron Medical at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound (time frame: Baseline and 16 weeks (4 weeks treatment + 12 week follow up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02748928, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.