Subcutaneous Adipose TissueNCT01853397
Evaluation of the Treatment of Adipose Tissue With Liposonix System (Model 2) Using a New Treatment Method
A study testing Liposonix System (Model 2) in people with Subcutaneous Adipose Tissue, run by Solta Medical at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, efficacy, and tolerability of treatment with the Liposonix System (Model 2)using a single pass technique. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Subcutaneous Adipose Tissue
- What is being tested?
- Liposonix System (Model 2)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to Feb 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, 18 to 65 years of age
- Body Mass Index of ≤30 kg/m2
- Thickness of subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.3 cm
- Subjects must agree to not alter their normal and regular diet or exercise routines during the course of the study
- Subject must understand the nature of the study and sign an IRB approved Informed Consent
Who cannot join
- Subject is pregnant
- Subject is 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 prior aesthetic procedures to the region to be treated
- Subject has had previous open or laparoscopic surgery in the anticipated treatment area
- Subject is on prescription or over the counter weight reduction medication or programs, or had weight reduction procedures
Show all 11Show fewer
- Subjects undergoing chronic steroid or immunosuppressive therapy
- Subject has cardiac pacemakers or any implantable electrical device
- Subject has a History of cancer
- Subject has sensory loss or dysesthesia in the area to be treated
- Subjects who are unable, or lack the capacity, to self consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jewell Plastic Surgery Center
Eugene, Oregon, 97401
Solta Medical Aesthetic Center
Hayward, California, 94545
About this study
Official title: An Evaluation of the Safety and Effectiveness of Treatment of Adipose Tissue With the Liposonix System (Model 2) Using a New Treatment Method
The purpose of this study is to evaluate the safety, efficacy, and tolerability of treatment with the Liposonix System (Model 2)using a single pass technique.
- Conditions
- Subcutaneous Adipose Tissue
- Being tested
- Liposonix System (Model 2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposonix System (Model 2)Device
| Study group | Role | What they receive |
|---|---|---|
| Treatment at level 1 | Experimental | Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2) Receives: Device: Liposonix System (Model 2) |
| Treatment at level 2 | Experimental | Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2) Receives: Device: Liposonix System (Model 2) |
| Treatment at level 3 | Experimental | Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2) Receives: Device: Liposonix System (Model 2) |
| Treatment with 3 passes at 60 J/cm2 | Active comparator | Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence) Receives: Device: Liposonix System (Model 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline
Change from baseline in waist circumference 12 weeks after treatment was assessed by blinded evaluators.
Measured: 12 weeks
Secondary outcomes (4)
Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline
Change from baseline in waist circumference 4, 8, and 16 weeks after treatment was assessed by blinded evaluators.
Measured: 4 weeks, 8 weeks, 16 weeks
Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)
GAIS evaluations were performed by Investigators at the 4, 8, 12, and 16 week visits. Investigators used direct visual assessment (live assessment) compared to photographs of subjects taken before treatment (baseline) to assess improvement in the treatment area.
Scoring was based upon a five point grading System: 5 - Much Improved, 4 - Improved, 3 - No Change, 2 - Worse, or 1 - Much Worse. The definition of an improvement of the GAIS score included either a GAIS score of 'Improved' or 'Much Improved'.
Measured: 4, 8, 12, and 16 weeks
Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)
Subjects self-assessed improvement in the treatment area and assigned a GAIS score at each visit. Scoring was based upon a five point grading System: 5 - Much Improved, 4 - Improved, 3 - No Change, 2 - Worse, or 1 - Much Worse. The definition of an improvement of the GAIS score included either a GAIS score of 'Improved' or 'Much Improved'.
Measured: 4, 8, 12, and 16 weeks
Subject Satisfaction With Treatment
Subjects rated their satisfaction with treatment results using a 5-point Likert Satisfaction Scale (5: very satisfied; 4: satisfied; 3: neither satisfied nor dissatisfied; 2: dissatisfied; 1: very dissatisfied). The subject satisfaction score was analyzed as the proportion of subjects showing improvement as defined as a score of 4 or greater ('satisfied' or 'very satisfied').
Measured: 4, 8, 12, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2014
- Study completionFeb 2014
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.
- Other trials for Subcutaneous Adipose TissueStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solta Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Jewell, MD, Principal investigator, Jewell Plastic Surgery CenterRonald Wheeland, MD, Principal investigator, Solta Medical Aesthetic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853397
- Sponsor's protocol ID
- 13-137-LP-H
- Status last verified
- Mar 2015
- First submitted
- 8 May 2013
- Last updated
- 16 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Safety and Effectiveness of Treatment of Adipose Tissue With the Liposonix System (Model 2) Using a New Treatment Method
- ClinicalTrials.gov ID
- NCT01853397
- Acronym / sponsor ID
- 13-137-LP-H
- Conditions
- Subcutaneous Adipose Tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Solta MedicalIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 15 May 2013 (estimated)
- Results
- Posted 27 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, efficacy, and tolerability of treatment with the Liposonix System (Model 2)using a single pass technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment at level 1 | Experimental | Device: Liposonix System (Model 2)Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2) |
| Treatment at level 2 | Experimental | Device: Liposonix System (Model 2)Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2) |
| Treatment at level 3 | Experimental | Device: Liposonix System (Model 2)Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2) |
| Treatment with 3 passes at 60 J/cm2 | Active comparator | Device: Liposonix System (Model 2)Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, 18 to 65 years of age
- Body Mass Index of ≤30 kg/m2
- Thickness of subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.3 cm
- Subjects must agree to not alter their normal and regular diet or exercise routines during the course of the study
- Subject must understand the nature of the study and sign an IRB approved Informed Consent
Key exclusion criteria (11 listed)
- Subject is pregnant
- Subject is 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 prior aesthetic procedures to the region to be treated
- Subject has had previous open or laparoscopic surgery in the anticipated treatment area
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 System (Model 2) | Device | Treatment at level 1, Treatment at level 2, Treatment at level 3, Treatment with 3 passes at 60 J/cm2 |
Primary outcome
Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline
Time frame: 12 weeks
Change from baseline in waist circumference 12 weeks after treatment was assessed by blinded evaluators.
4 secondary outcomes
Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline
Time frame: 4 weeks, 8 weeks, 16 weeks
Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)
Time frame: 4, 8, 12, and 16 weeks
Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)
Time frame: 4, 8, 12, and 16 weeks
Subject Satisfaction With Treatment
Time frame: 4, 8, 12, and 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mark Jewell, MD principal investigator
Jewell Plastic Surgery Center
Ronald Wheeland, MD principal investigator
Solta Medical Aesthetic Center
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 System (Model 2) in people with Subcutaneous Adipose Tissue, run by Solta 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 5 inclusion and 11 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 16 Apr 2015. 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?
Yes. Results are posted in the registry (first posted 27 Mar 2015). 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 Waist Circumference 12 Weeks After Treatment as Compared to Baseline (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 16 Apr 2015.