Body SculptingNCT01104272
Subcutaneous Contouring Using High Intensity Focused Ultrasound
A study testing LipoSonix (Ultrasound treatment of Subcutaneous Adipose Tissue) in people with Body Sculpting, run by Medicis Technologies Corporation at 2 sites in Canada.
Trial summary
The device delivers High Intensity Focused Ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to body sculpting, such as a reduction in waist circumference. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Body Sculpting
- What is being tested?
- LipoSonix (Ultrasound treatment of Subcutaneous Adipose Tissue)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2010to Jan 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All of the following inclusion criteria must be met at the time of screening before the subject is enrolled into the study:
- Male or female subjects, 18 to 65 years of age
- Body Mass Index ≤30
- Thickness of subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.5 cm
- Subjects must agree to not alter their normal and regular diet or exercise routines during the course of the study.
- Subjects must be of African descent AND have Fitzpatrick skin types IV, V, or VI.
Who cannot join
- A subject is ineligible to participate in this study if they meet any of the following exclusion criteria at screening:
- Female subject who is pregnant (i.e., has a positive urine pregnancy test), is suspected to be pregnant, or is lactating or becomes pregnant during the course of the study. (NOTE: Females of childbearing potential must have a negative urine pregnancy test prior to enrollment in the study.)
- Subjects diagnosed with coagulation disorders or are receiving anticoagulant therapy or medications or dietary supplements which impede coagulation or platelet aggregation.
- Subject has diabetes or cardiovascular disease.
- Subject has had any aesthetic procedure to the region to be treated.
- Subject has systemic skin disease or skin disease in the areas to be treated.
Show all 18Show fewer
- Subject has any abnormality of the skin or soft tissues of the abdominal wall in the areas to be treated.
- Subject has had previous open or laparoscopic surgery in the anticipated treatment area.
- Subjects is on prescription or over the counter weight reduction medication or programs, or had weight reduction procedures (e.g.: gastric bypass, Lap-Band, etc.)
- Subject has skin or superficial tissue that does not lie flat on its own when the subject is in the supine position.
- Subjects undergoing chronic steroid or immunosuppressive therapy.
- Subjects who have cardiac pacemakers or any implantable electrical device, e.g. pacemaker, defibrillator, or neurostimulators.
- Subjects who have metal implants of any type in the area to be treated.
- History of cancer.
- Subjects who have sensory loss or dysesthesia in the area to be treated.
- Subject currently uses illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day).
- Subjects who cannot adhere to the study visit schedule (e.g., subjects not likely to stay in the study for a maximum of 27 weeks - screening through exit visit).
- Subjects who are unable, or lack the capacity, to self consent.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Institute of Cosmetic and Laser Surgery
Oakville, Ontario, L6J7W5
Dr. Nowell Solish Private Office
Toronto, Ontario, M5R3N8
About this study
Official title: An Evaluation of the Treatment of Adipose Tissue Using a Focused Ultrasound Device in Subjects With Fitzpatrick IV-VI Skin Types
The device delivers High Intensity Focused Ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to body sculpting, such as a reduction in waist circumference.
- Conditions
- Body Sculpting
- Being tested
- LipoSonix (Ultrasound treatment of Subcutaneous Adipose Tissue)
- Keywords
- Ultrasound Treatment of Subcutaneous Adipose Tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipoSonix (Ultrasound treatment of Subcutaneous Adipose Tissue)Device
Study of Adipose Tissue Treatment Using Focused Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Energy Level 1 | Experimental | Subcutaneous Adipose Tissue Treated With Energy Level 1. Receives: Device: LipoSonix (Ultrasound treatment of Subcutaneous Adipose Tissue) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in waist circumference
Measured: 12 weeks
Secondary outcomes (11)
The change from Baseline in waist circumference measured after treatment, for the average of the two waist circumference measurements at the iliac crest as well as for each of the individual measurements.
Measured: 4 weeks
The change from Baseline in waist circumference measured after treatment, for the average of the two waist circumference measurements at the iliac crest as well as for each of the individual measurements.
Measured: 8 weeks
Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment.
Measured: 1 week
Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment.
Measured: 4 weeks
Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment.
Measured: 8 weeks
Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment.
Measured: 12 weeks
Visual Analog Scale (VAS) diary to record post treatment discomfort.
Measured: 1 week
Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator.
Measured: 1 week
Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator.
Measured: 4 weeks
Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator.
Measured: 8 weeks
Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body SculptingStudies 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medicis Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nowell Solish, MD, Principal investigator, Dr. Nowell Solish Private OfficeSheetal Sapra, MD, Principal investigator, Institute of Cosmetic and Laser Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104272
- Sponsor's protocol ID
- LP-1100-05
- Status last verified
- Jan 2011
- First submitted
- 9 Apr 2010
- Last updated
- 19 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Treatment of Adipose Tissue Using a Focused Ultrasound Device in Subjects With Fitzpatrick IV-VI Skin Types
- ClinicalTrials.gov ID
- NCT01104272
- Acronym / sponsor ID
- LP-1100-05
- Conditions
- Body Sculpting
- Keywords
- Ultrasound Treatment of Subcutaneous Adipose Tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Medicis Technologies CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 15 Apr 2010 (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.
The device delivers High Intensity Focused Ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to body sculpting, such as a reduction in waist circumference.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Energy Level 1 | Experimental | Device: LipoSonix (Ultrasound treatment of Subcutaneous Adipose Tissue)Subcutaneous Adipose Tissue Treated With Energy Level 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All of the following inclusion criteria must be met at the time of screening before the subject is enrolled into the study:
- Male or female subjects, 18 to 65 years of age
- Body Mass Index ≤30
- Thickness of subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.5 cm
- Subjects must agree to not alter their normal and regular diet or exercise routines during the course of the study.
Key exclusion criteria (18 listed)
- A subject is ineligible to participate in this study if they meet any of the following exclusion criteria at screening:
- Female subject who is pregnant (i.e., has a positive urine pregnancy test), is suspected to be pregnant, or is lactating or becomes pregnant during the course of the study. (NOTE: Females of childbearing potential must have a negative urine pregnancy test prior to enrollment in the study.)
- Subjects diagnosed with coagulation disorders or are receiving anticoagulant therapy or medications or dietary supplements which impede coagulation or platelet aggregation.
- Subject has diabetes or cardiovascular disease.
- Subject has had any aesthetic procedure to the region to be treated.
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 |
|---|---|---|
| LipoSonix (Ultrasound treatment of Subcutaneous Adipose Tissue)Study of Adipose Tissue Treatment Using Focused Ultrasound | Device | Energy Level 1 |
Primary outcome
Change from baseline in waist circumference
Time frame: 12 weeks
11 secondary outcomes
The change from Baseline in waist circumference measured after treatment, for the average of the two waist circumference measurements at the iliac crest as well as for each of the individual measurements.
Time frame: 4 weeks
The change from Baseline in waist circumference measured after treatment, for the average of the two waist circumference measurements at the iliac crest as well as for each of the individual measurements.
Time frame: 8 weeks
Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment.
Time frame: 1 week
Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment.
Time frame: 4 weeks
Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment.
Time frame: 8 weeks
Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment.
Time frame: 12 weeks
Visual Analog Scale (VAS) diary to record post treatment discomfort.
Time frame: 1 week
Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator.
Time frame: 1 week
Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator.
Time frame: 4 weeks
Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator.
Time frame: 8 weeks
Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2011.
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.
Nowell Solish, MD principal investigator
Dr. Nowell Solish Private Office
Sheetal Sapra, MD principal investigator
Institute of Cosmetic and Laser Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LipoSonix (Ultrasound treatment of Subcutaneous Adipose Tissue) in people with Body Sculpting, run by Medicis Technologies Corporation at 2 sites in Canada.
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 6 inclusion and 18 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 Jan 2011. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from baseline in waist circumference (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2011.