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Multi-center, prospective, open-label, single arm study. The study aims to evaluate the safety and efficacy of Laser Assisted Liposuction procedure performed with the LipoLife system. The study will include twenty (20) eligible subjects, that are willing to undergo abdominal or outer thighs laser-assisted liposuction. Five to twenty (5-20) subjects out of this study group should also be eligible for facial fat grafting. Follow up visits to evaluate study endpoints will take place at 1, 3 and 6 months after the surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser assisted liposuction | Experimental | Laser Assisted Liposuction with the LipoLife system. Each subject underwent laser assisted liposuction surgery w/wo facial fat grafting , using the LipoLifeTM system. Pre-surgery evaluation visit was carried out 1 week prior to the surgery. Follow up visits to evaluate safety and efficacy will take place at 1, 3 and 6 months after the surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LipoLife system | Device | Abdominal/ Outer thighs Laser Assisted Liposuction. Five to twenty subjects out of the study group will also undergo facial fat grafting. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correct Identification of Before and After Photographs | Over 90% success in correct identification of before and after body contouring photos by blinded evaluators. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason N. Pozner, M.D. | Sanctuary Plastic Surgery | Principal Investigator |
| Lior Heller, M.D. | Yitzhak Shamir Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanctuary Plastic Surgery | Boca Raton | Florida | 33431 | United States | ||
| Yitzhak Shamir Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Laser Assisted Liposuction of Abdominal Excessive Fat | Laser Assisted Liposuction with the LipoLife system. LipoLife system: Abdominal/ Outer thighs Laser Assisted Liposuction. Added: "Each subject underwent laser assisted liposuction surgery w/wo facial fat grafting , using the LipoLifeTM system. Pre-surgery evaluation visit was carried out 1 week prior to the surgery. Follow up visits to evaluate safety and efficacy will take place at 1, 3 and 6 months after the surgery." Seven subjects out of the study group underwent facial fat grafting. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Laser Assisted Liposuction | Laser Assisted Liposuction with the LipoLife system. LipoLife system: Abdominal/ Outer thighs Laser Assisted Liposuction. Seven subjects out of the study group underwent facial fat grafting. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Correct Identification of Before and After Photographs | Over 90% success in correct identification of before and after body contouring photos by blinded evaluators. | Posted | Count of Participants | Participants | 3 months |
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Duration of each subject's participation was up to 8 months from enrollment to termination. Adverse events data was to be reported at any time during or after the use of the study device.
Definitions of adverse event and serious adverse event used to collect adverse event information do not differ from the clinicaltrials.gov Definitions
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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 | Laser Assisted Liposuction | Laser Assisted Liposuction with the LipoLife system. LipoLife system: Abdominal/ Outer thighs Laser Assisted Liposuction. Five to twenty subjects out of the study group will also undergo facial fat grafting. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment | localized bleeding outside of skin blood vessels. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Meital Grafi-Cohen | Alma Lasers | +972-523708780 | meital.grafi@almalasers.co.il |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2018 | Sep 4, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 1, 2018 | Sep 4, 2022 | ICF_002.pdf |
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| Be’er Ya‘aqov |
| Israel |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 20 |
| 0 |
| 20 |
| 2 |
| 20 |
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| urinary track infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment | An infection in the urinary system that begins when microorganisms cling to the opening of the urethra (the canal from the bladder) and begin to multiply. |
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