Excess Abdominal FatNCT02700152
Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Device for Non-Invasive Abdominal Fat Reduction
A study testing UltraShape in people with Excess Abdominal Fat, run by Syneron Medical at 2 sites in United States.
Trial summary
Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the UltraShape treatment for non-invasive abdominal fat reduction. Study subjects will undergo UltraShape treatments on the abdominal area 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2016to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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).
- BMI interval: 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
2 sites in 1 country.
Jeffrey S Dover, M.D contact
United States2 sites, 1 recruiting
- Completed
Skin Care Physicians
Chestnut Hill, Massachusetts, 02467
- Recruiting
Zel Skin & Laser Specialists
Edina, Minnesota, 55402
Brian Zelickson, MD, 952-929-8888
About this study
Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the UltraShape treatment for non-invasive abdominal fat reduction.
Study subjects will undergo UltraShape treatments on the abdominal area
Read the detailed description
This study is a prospective, baseline and blinded controlled, one arm clinical study showing the performance and safety of the UltraShape treatment for non-invasive abdominal fat reduction.
Up to 60 Healthy subjects in up to 4 investigational sites will be enrolled in this study. All subjects will undergo an assessment of their general health. During the treatment period, subject's fat thickness and circumference will be measured and three successive UltraShape treatments, two weeks interval, will be performed.
The study subjects will undergo UltraShape treatments on the abdomen. During the follow-up period visit will be conducted as follow: 4 weeks (4wk FU), 8 weeks (8wk FU) and 12 weeks (12wk FU) post last treatment (Tx.3). Subject's abdominal fat thickness and circumference will be measured in 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltraShapeDevice
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 |
|---|---|---|
| all subjects | Experimental | Eligible subjects will receive 3 treatments, 2 weeks interval, with the UltraShape 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal fat thickness Reduction
Abdominal fat thickness Reduction post UltraShape treatments at 12 weeks follow-up (12wk FU) versus baseline
Measured: 16 weeks
Secondary outcomes (7)
Evaluate the safety of the treatment
Evaluate the safety of the treatment with the UltraShape device on abdominal area
Measured: day 0 until 16 weeks
Abdominal fat thickness reduction as measured by Ultrasound
Abdominal fat thickness reduction as measured by Ultrasound device post UltraShape treatments at all follow-up visits (4wk FU, 8wk FU, and 12wk FU) versus baseline
Measured: 8wk , 12wk , and 16wk
Abdominal fat thickness reduction as measured by caliper
Abdominal fat thickness reduction as measured by caliper post UltraShape treatments at all follow-up visits (4wk FU, 8wk FU, and 12wk FU) versus baseline
Measured: 8wk , 12wk , and 16wk
Abdominal circumference reduction
Abdominal circumference reduction post UltraShape treatments at all visits (treatments (pre Tx. 2; pre Tx.3) and follow up (4wk FU, 8wk FU, and 12wk FU)) versus baseline
Measured: 2 weeks , 4 weeks, 8wk , 12wk , and 16wk
Investigator satisfaction:
Satisfaction assessment will be performed independently by the investigator himself using 5 points Likert scale questionnaire at all follow-up visits (4wk FU, 8wk FU and 12wk FU)
Measured: 8wk , 12wk , and 16wk
Subject satisfaction:
Satisfaction assessment will be performed independently by the subject himself using 5 points Likert scale questionnaire at all follow-up visits (4wk FU, 8wk FU, and 12wk FU).
Measured: 8wk , 12wk , and 16wk
Comfort level during treatment:
Comfort assessment will be performed independently by the subject himself using a numerical scale. The subjects will answer this questionnaire after each of the three treatments
Measured: day 0 , 2 weeks , 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey S Dover, M.D., Principal investigator, SkinCare Physicians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700152
- Sponsor's protocol ID
- DHF18531
- Status last verified
- Feb 2018
- First submitted
- 25 Feb 2016
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hexsel D, Serra M, Mazzuco R, Dal'Forno T, Zechmeister D. Phosphatidylcholine in the treatment of localized fat. J Drugs Dermatol. 2003 Oct;2(5):511-8.
PubMed 14558399Weinstein Velez M, Ibrahim O, Petrell K, Dover JS. Nonthermal Pulsed Ultrasound Treatment for the Reduction in Abdominal Fat: A Pilot Study. J Clin Aesthet Dermatol. 2018 Sep;11(9):32-36. Epub 2018 Sep 1.
PubMed 30319729
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. 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 Device for Non-Invasive Abdominal Fat Reduction
- ClinicalTrials.gov ID
- NCT02700152
- Acronym / sponsor ID
- DHF18531
- Conditions
- Excess Abdominal Fat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the UltraShape treatment for non-invasive abdominal fat reduction.
Study subjects will undergo UltraShape treatments on the abdominal area
Detailed description
This study is a prospective, baseline and blinded controlled, one arm clinical study showing the performance and safety of the UltraShape treatment for non-invasive abdominal fat reduction.
Up to 60 Healthy subjects in up to 4 investigational sites will be enrolled in this study. All subjects will undergo an assessment of their general health. During the treatment period, subject's fat thickness and circumference will be measured and three successive UltraShape treatments, two weeks interval, will be performed.
The study subjects will undergo UltraShape treatments on the abdomen. During the follow-up period visit will be conducted as follow: 4 weeks (4wk FU), 8 weeks (8wk FU) and 12 weeks (12wk FU) post last treatment (Tx.3). Subject's abdominal fat thickness and circumference will be measured in 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 |
|---|---|---|
| all subjects | Experimental | Device: UltraShapeEligible subjects will receive 3 treatments, 2 weeks interval, with the UltraShape 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 |
|---|---|---|
| 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 | all subjects |
Primary outcome
Abdominal fat thickness Reduction
Time frame: 16 weeks
Abdominal fat thickness Reduction post UltraShape treatments at 12 weeks follow-up (12wk FU) versus baseline
7 secondary outcomes
Evaluate the safety of the treatment
Time frame: day 0 until 16 weeks
Abdominal fat thickness reduction as measured by Ultrasound
Time frame: 8wk , 12wk , and 16wk
Abdominal fat thickness reduction as measured by caliper
Time frame: 8wk , 12wk , and 16wk
Abdominal circumference reduction
Time frame: 2 weeks , 4 weeks, 8wk , 12wk , and 16wk
Investigator satisfaction:
Time frame: 8wk , 12wk , and 16wk
Subject satisfaction:
Time frame: 8wk , 12wk , and 16wk
Comfort level during treatment:
Time frame: day 0 , 2 weeks , 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Background: PubMed 14558399Hexsel D, Serra M, Mazzuco R, Dal'Forno T, Zechmeister D. Phosphatidylcholine in the treatment of localized fat. J Drugs Dermatol. 2003 Oct;2(5):511-8.
- Derived from this study: PubMed 30319729Weinstein Velez M, Ibrahim O, Petrell K, Dover JS. Nonthermal Pulsed Ultrasound Treatment for the Reduction in Abdominal Fat: A Pilot Study. J Clin Aesthet Dermatol. 2018 Sep;11(9):32-36. Epub 2018 Sep 1.
- Individual participant dataSharing planned: Undecided
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.
Jeffrey S Dover, M.D contact
Jeffrey S Dover, M.D. principal investigator
SkinCare Physicians
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UltraShape in people with Excess Abdominal Fat, run by Syneron Medical at 2 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: status not confirmed, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey S Dover, M.D ((617) 731-1600), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal fat thickness Reduction (time frame: 16 weeks). 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 NCT02700152, which also lists 2 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 Feb 2018.