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This is a prospective, open-labeled, non-randomized, multi-center clinical study to collect safety and efficacy data on the TempSure Firm. The intended use of the TempSure device is to use the Firm handpieces for non-invasive lipolysis.
Up to 12 subjects will be enrolled at up to 3 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive 1 treatment on the abdomen with the TempSure firm. Subjects will undergo abdominoplasty surgery at one of 4 predetermined timepoint after an abdomen treatment: day 0 (within 24 hours after treatment), 10 days (+/- 3 days), 20 days (+/- 3 days), or 30 days (+/- 7 days). This will be determined by the availability of the subject and/or an as needed basis and this will be decided by the Investigator and the Sponsor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TempSure Firm Day 0 Biopsy Group | Experimental | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 0 (within 24 hours after treatment). |
|
| TempSure Firm Day 10 Biopsy Group | Experimental | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 10 (+/- 3 days) after treatment. |
|
| TempSure Firm Day 20 Biopsy Group | Experimental | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 20 (+/- 3 days) after treatment. |
|
| TempSure Firm Day 30 Biopsy Group | Experimental | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 30 (+/- 7 days) after treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TempSure Firm | Device | The TempSure firm will be used on the abdomen for non-invasive lipolysis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Histology of Biopsy | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm within 24 hours post treatment. The samples were looked at from a qualitative standpoint to determine of whether the samples had signs of adipocyte injury and/or inflammatory tissue response, and if there was dermal/epidermal tissue injury (which was assessed by a qualified histologist). | within 24 hours post treatment |
| Histology of Biopsy | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 10 (+/- 3 days) after treatment. The samples were looked at from a qualitative standpoint to determine of whether the samples had signs of adipocyte injury and/or inflammatory tissue response, and if there was dermal/epidermal tissue injury (which was assessed by a qualified histologist). | within 10 days (+/- 3 days) post treatment |
| Histology of Biopsy | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 20 (+/- 3 days) after treatment. The samples were looked at from a qualitative standpoint to determine of whether the samples had signs of adipocyte injury and/or inflammatory tissue response, and if there was dermal/epidermal tissue injury (which was assessed by a qualified histologist). | within 20 days (+/- 3 days) post treatment |
| Histology of Biopsy | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 30 (+/- 3 days) after treatment. The samples were looked at from a qualitative standpoint to determine of whether the samples had signs of adipocyte injury and/or inflammatory tissue response, and if there was dermal/epidermal tissue injury (which was assessed by a qualified histologist). | within 30 days (+/- 7 days) post treatment |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning to become pregnant prior to the end of the study.
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Civiok | Cynosure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bass Plastic Surgery PLLC | New York | New York | 10065 | United States | ||
| Aesthetic Pavilion Ambulatory Surgery Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31896400 | Background | Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TempSure Firm Day 0 Biopsy Group | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 0 (within 24 hours after treatment). TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis. |
| FG001 | TempSure Firm Day 10 Biopsy Group | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 10 (+/- 3 days) after treatment. TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis. |
| FG002 | TempSure Firm Day 20 Biopsy Group | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 20 (+/- 3 days) after treatment. TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis. |
| FG003 | TempSure Firm Day 30 Biopsy Group | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 30 (+/- 7 days) after treatment. TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TempSure Firm Day 0 Biopsy Group | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 0 (within 24 hours after treatment). TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis. |
| BG001 | TempSure Firm Day 10 Biopsy Group |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Histology of Biopsy | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm within 24 hours post treatment. The samples were looked at from a qualitative standpoint to determine of whether the samples had signs of adipocyte injury and/or inflammatory tissue response, and if there was dermal/epidermal tissue injury (which was assessed by a qualified histologist). | Posted | Count of Participants | Participants | within 24 hours post treatment |
|
Adverse Events (AE) occurring were captured and followed up throughout the study duration, approximately 2 months.
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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 | TempSure Firm Day 0 Biopsy Group | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 0 (within 24 hours after treatment). TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Trimper | Cynosure | 9788776342 | jamie.trimper@cynosure.com |
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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 | Mar 5, 2021 | Mar 1, 2022 | Prot_SAP_000.pdf |
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There are 4 different arms, each with different time frames based on thei subjects' availability. Each group uses the same device and treatment parameters, with the only difference being when follow up measures are taken.
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| Staten Island |
| New York |
| 10306 |
| United States |
Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 10 (+/- 3 days) after treatment. TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis. |
| BG002 | TempSure Firm Day 20 Biopsy Group | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 20 (+/- 3 days) after treatment. TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis. |
| BG003 | TempSure Firm Day 30 Biopsy Group | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 30 (+/- 7 days) after treatment. TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| FitzPatrick Skin Type | The Fitzpatrick Skin Score is used to determine skin color. It is a numerical system that classifies skin into six types (Type I, Type II, Type III, Type IV, Type V and Type VI) based on the numerical score achieved (ranging from 0 to 36). The lower the score (and skin type number), the fairer the skin. The higher the score (and skin type number), the more deeply pigmented the skin is. The scale comes from the source listed in the references. | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Histology of Biopsy | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 10 (+/- 3 days) after treatment. The samples were looked at from a qualitative standpoint to determine of whether the samples had signs of adipocyte injury and/or inflammatory tissue response, and if there was dermal/epidermal tissue injury (which was assessed by a qualified histologist). | Posted | Number | participants | within 10 days (+/- 3 days) post treatment |
|
|
|
| Primary | Histology of Biopsy | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 20 (+/- 3 days) after treatment. The samples were looked at from a qualitative standpoint to determine of whether the samples had signs of adipocyte injury and/or inflammatory tissue response, and if there was dermal/epidermal tissue injury (which was assessed by a qualified histologist). | Posted | Number | participants | within 20 days (+/- 3 days) post treatment |
|
|
|
| Primary | Histology of Biopsy | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 30 (+/- 3 days) after treatment. The samples were looked at from a qualitative standpoint to determine of whether the samples had signs of adipocyte injury and/or inflammatory tissue response, and if there was dermal/epidermal tissue injury (which was assessed by a qualified histologist). | Posted | Number | participants | within 30 days (+/- 7 days) post treatment |
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| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | TempSure Firm Day 10 Biopsy Group | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 10 (+/- 3 days) after treatment. TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | TempSure Firm Day 20 Biopsy Group | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 20 (+/- 3 days) after treatment. TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | TempSure Firm Day 30 Biopsy Group | Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 30 (+/- 7 days) after treatment. TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis. | 0 | 3 | 0 | 3 | 0 | 3 |
The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.