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The objectives of this study are to evaluate the safety and effectiveness of procedural analgesia for improvements in tolerability of treatment with the Liposonix System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposonix with pre-treatment analgesia | Experimental | Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposonix System (Model 2) | Device | Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score for Overall Treatment | Following treatment, the subject was asked to evaluate the pain level for the overall treatment using the 0-10 Visual Analog Scale (0 represents no pain and 10 represents worst imaginable pain) | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment | Adverse events will be assessed and documented throughout the study | Baseline, 1 day, 1 week |
| Pain Scores Reported at 1-day Post-Treatment | During the 1-day follow-up phone call, subjects were asked to rate the pain they were currently experiencing from the Liposonix treatment using a 0-10 pain scale (0 represents no pain and 10 represents worst pain imaginable). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Wheeland, MD | Principal Investigator | |
| Reid Rubsamen, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Solta Medical Aesthetic Center | Hayward | California | 94545 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposonix With Pre-treatment Analgesia | Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone) Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2). Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent-to-Treat
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposonix With Pre-treatment Analgesia | Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone) Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2). Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone) |
| 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 | Pain Score for Overall Treatment | Following treatment, the subject was asked to evaluate the pain level for the overall treatment using the 0-10 Visual Analog Scale (0 represents no pain and 10 represents worst imaginable pain) | Intent to Treat | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
Adverse event data were collected from day 0 through study follow-up (1 week post-treatment)
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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 | Liposonix With Pre-treatment Analgesia | Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone) Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2). Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Car Accident | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient admitted to hospital following car accident for lower back pain. Unrelated to treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain during treatment | General 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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| Pre-treatment analgesia | Drug | Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone) |
|
| 1 day |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Safety Assessment | Adverse events will be assessed and documented throughout the study | Not Posted | Baseline, 1 day, 1 week |
| Secondary | Pain Scores Reported at 1-day Post-Treatment | During the 1-day follow-up phone call, subjects were asked to rate the pain they were currently experiencing from the Liposonix treatment using a 0-10 pain scale (0 represents no pain and 10 represents worst pain imaginable). | Intent-to-Treat | Posted | Mean | Standard Deviation | units on a scale | 1 day |
|
|
|
| 1 |
| 11 |
| 11 |
| 11 |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Tenderness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Soreness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Tingling/Altered Sensation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Edema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Nausea/Vomiting | General disorders | Non-systematic Assessment |
|
| Dizziness/Feeling Faint | General disorders | Non-systematic Assessment |
|
| Warm sensation on treatment area | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Surface sensitivity/soreness at treatment site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Tiredness | General disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Feeling cold | General disorders | Non-systematic Assessment |
|
| Bruising at attempted IV site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Burning sensation to touch | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pain with movement | General disorders | Non-systematic Assessment |
|
| Sense of pressure at treatment site | General disorders | Non-systematic Assessment |
|
| Flu-like symptoms | General disorders | Non-systematic Assessment |
|
Investigator shall notify Sponsor of the intent to publish or present independent Study Data, and agrees not to publish or publicly present and/or discuss such data, Investigator's current findings and/or the results of the Study independently without the express written consent of Sponsor, which consent may be withheld. Prior to submission for publication or presentation, all draft manuscripts must be submitted, reviewed and approved by Sponsor for confidential material.