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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment at level 1 | Experimental | Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2) |
|
| Treatment at level 2 | Experimental | Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2) |
|
| Treatment at level 3 | Experimental | 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 | Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposonix System (Model 2) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks, 8 weeks, 16 weeks |
| Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Jewell, MD | Jewell Plastic Surgery Center | Principal Investigator |
| Ronald Wheeland, MD | Solta Medical Aesthetic Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Solta Medical Aesthetic Center | Hayward | California | 94545 | United States | ||
| Jewell Plastic Surgery Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment at Level 1 | Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2) Liposonix System (Model 2) |
| FG001 | Treatment at Level 2 | Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2) Liposonix System (Model 2) |
| FG002 | Treatment at Level 3 | Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2) Liposonix System (Model 2) |
| FG003 | Treatment With 3 Passes at 60 J/cm2 | Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence) Liposonix System (Model 2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment at Level 1 | Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2) Liposonix System (Model 2) |
| BG001 | Treatment at Level 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-treat | Posted | Mean | Standard Deviation | cm | 12 weeks |
|
Adverse events were collected from day 0 through study exit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment at Level 1 | Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2) Liposonix System (Model 2) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Programs | Solta Medical | 510-259-5284 | aloncaric@solta.com |
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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'. |
| 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'. | 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'). | 4, 8, 12, and 16 weeks |
| Eugene |
| Oregon |
| 97401 |
| United States |
| Subject Noncompliance |
|
Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)
Liposonix System (Model 2)
| BG002 | Treatment at Level 3 | Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2) Liposonix System (Model 2) |
| BG003 | Treatment With 3 Passes at 60 J/cm2 | Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence) Liposonix System (Model 2) |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| OG002 | Treatment at Level 3 | Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2) Liposonix System (Model 2) |
| OG003 | Treatment With 3 Passes at 60 J/cm2 | Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence) Liposonix System (Model 2) |
|
|
| Secondary | 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. | Intent-to-treat | Posted | Mean | Standard Deviation | cm | 4 weeks, 8 weeks, 16 weeks |
|
|
|
| Secondary | 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'. | Intent-to-treat | Posted | Number | Percentage of subjects improved | 4, 8, 12, and 16 weeks |
|
|
|
| Secondary | 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'. | Intent-to-treat | Posted | Number | percentage of subjects improved | 4, 8, 12, and 16 weeks |
|
|
|
| Secondary | 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'). | Intent-to-treat | Posted | Number | percentage of subjects satisfied | 4, 8, 12, and 16 weeks |
|
|
|
| 0 |
| 18 |
| 18 |
| 18 |
| EG001 | Treatment at Level 2 | Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2) Liposonix System (Model 2) | 0 | 20 | 20 | 20 |
| EG002 | Treatment at Level 3 | Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2) Liposonix System (Model 2) | 0 | 17 | 17 | 17 |
| EG003 | Treatment With 3 Passes at 60 J/cm2 | Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence) Liposonix System (Model 2) | 0 | 17 | 17 | 17 |
| Nausea/vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Abdominal discomfort | General disorders | Non-systematic Assessment |
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| Burning sensation | General disorders | Non-systematic Assessment |
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| Ecchymosis | General disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Pyrexia | General disorders | Non-systematic Assessment |
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| Pain during treatment | General disorders | Non-systematic Assessment |
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| Pain/tenderness | General disorders | Non-systematic Assessment |
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| Paresthesia | General disorders | Non-systematic Assessment |
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| Lumps/bumps | General disorders | Non-systematic Assessment |
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| Soreness/discomfort | General disorders | Non-systematic Assessment |
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| Swelling | General disorders | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | Non-systematic Assessment |
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| Upper resp. tract infection | Infections and infestations | Non-systematic Assessment |
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| Infected arthropod bite | Infections and infestations | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Bone fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Vasovagal episode | Nervous system disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | Non-systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Angioedema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | Non-systematic Assessment |
|
Authorship and manuscript composition will reflect joint cooperation between the PI and Solta Medical personnel. Authorship will be established prior to the writing of the manuscript. No individual publications will be allowed prior to completion of the final report of the study except as agreed with Solta Medical. All publications must be reviewed and approved by Solta Medical prior to submission for publication.
| 8 weeks |
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| 16 weeks |
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| 8 weeks |
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| 12 weeks |
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| 16 weeks |
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| 8 weeks |
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| 12 weeks |
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| 16 weeks |
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| 8 weeks |
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| 12 weeks |
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| 16 weeks |
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