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The purpose of this study is to evaluate histological results of the treatments with the TempSure Firm handpiece on the flanks performed in the CYN20-FIRM-LIPO study.
Up to 10 subjects will be enrolled at up to 3 study centers. Subjects will receive 2 biopsies, 1 biopsy in the treatment area (the flanks) and 1 biopsy outside of the treatment area to serve as a control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Study Participants | Experimental | The TempSure will be used on the flanks during this study. Subjects will receive 1 biopsy in the treatment area on the flank. Subjects will also receive 1 biopsy sample on the contralateral side, where they did not receive treatment. Each subject had 1 control sample (tissue that was taken from an area where no treatment was received), and 1 treatment sample (tissue taken from an area that had been subjected to the treatment). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TempSure treatment | Device | Self-controlled, single-arm study using the TempSure device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Samples With Different Levels of Elastin When Compared to Baseline Samples From the Same Patient | Sections of skin were removed using the punch biopsy technique to render a microscopic diagnosis. Each specimen was preserved with a fixative and then stained using Hemotoxylin & Eosin, Verhoeff and Masson Red/Fast Green and/or nitroblue tetrazolium chloride (NBTC) staining methods. If using Hemotoxylin & Eosin, Verhoeff and Masson Red/Fast Green staining, samples were assessed and evaluated by the amount of elastin. If using NBTC staining, samples were assessed and evaluated to differentiate between the blue-stained viable cells and the unstained thermally damaged cells. The samples were examined by a qualified pathologist. The visual changes between the treated samples and the control samples were examined, with no typical unit of measure used to quantify the difference. Simply, control and treatment images were compared to each other with a qualitative analysis of the changes. The number of samples with different levels of elastin (control compared to treatment) is reported. | 1 Week (7-10 days) Post Baseline |
| Number of Treatment Samples With Different Levels of Dermis Collagen When Compared to Baseline Samples Taken From the Same Patient | Sections of skin were removed using the punch biopsy technique to render a microscopic diagnosis. Each specimen was preserved with a fixative and then stained using Hemotoxylin & Eosin, Verhoeff and Masson Red/Fast Green and/or nitroblue tetrazolium chloride (NBTC) staining methods. If using Hemotoxylin & Eosin, Verhoeff and Masson Red/Fast Green staining, samples were assessed and evaluated by the amount of collagen. If using NBTC staining, samples were assessed and evaluated to differentiate between the blue-stained viable cells and the unstained thermally damaged cells. The samples were examined by a qualified pathologist. The visual changes between the treated samples and the control samples were examined, with no typical unit of measure used to quantify the difference. Simply, control and treatment images were compared to each other with a qualitative analysis of the changes. The number of samples with different levels of collagen (control compared to treatment) is reported. | 1 Week (7-10 days) Post Baseline |
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Inclusion Criteria:
• Subject has completed their participation in the CYN20-FIRM-LIPO study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Civiok | Cynosure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JUVA Skin & Laser Center | New York | New York | 10022 | United States |
| 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 | All Study Participants | The TempSure will be used on the flanks during this study. Subjects will receive 1 biopsy in the treatment area on the flank. Subjects will also receive 1 biopsy sample on the contralateral side, where they did not receive treatment. Each subject had 1 control sample (tissue that was taken from an area where no treatment was received), and 1 treatment sample (tissue taken from an area that had been subjected to the treatment). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This study is described as only being composed of 1 arm because every subject underwent the same treatment procedure and had a control biopsy taken (in an area that was not treated) to be compared to the treatment biopsy.
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| ID | Title | Description |
|---|---|---|
| BG000 | TempSure Device | The TempSure will be used on the flanks during this study. TempSure treatment: Self-controlled, single-arm study using the TempSure device. |
| 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 | Number of Treatment Samples With Different Levels of Elastin When Compared to Baseline Samples From the Same Patient | Sections of skin were removed using the punch biopsy technique to render a microscopic diagnosis. Each specimen was preserved with a fixative and then stained using Hemotoxylin & Eosin, Verhoeff and Masson Red/Fast Green and/or nitroblue tetrazolium chloride (NBTC) staining methods. If using Hemotoxylin & Eosin, Verhoeff and Masson Red/Fast Green staining, samples were assessed and evaluated by the amount of elastin. If using NBTC staining, samples were assessed and evaluated to differentiate between the blue-stained viable cells and the unstained thermally damaged cells. The samples were examined by a qualified pathologist. The visual changes between the treated samples and the control samples were examined, with no typical unit of measure used to quantify the difference. Simply, control and treatment images were compared to each other with a qualitative analysis of the changes. The number of samples with different levels of elastin (control compared to treatment) is reported. | Posted | Number | biopsy samples | 1 Week (7-10 days) Post Baseline | biopsy samples | biopsy samples |
|
All adverse events were followed through study completion, an average of 7 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 | Treatment Flank | The TempSure was used on the flanks during this study. Subjects receive 1 biopsy in the treatment area on the flank. Each subject had 1 treatment sample (tissue taken from an area that had been subjected to the treatment). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain/tenderness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Trimper | Cynosure | (978) 256-4200 | jamie.trimper@cynosure.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2021 | Mar 8, 2022 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| FitzPatrick Skin Type | Measure Description: 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 used is cited in the reference section. | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | All Study Participants | The TempSure will be used on the flanks during this study. Subjects will receive 1 biopsy in the treatment area on the flank. Subjects will also receive 1 biopsy sample on the contralateral side, where they did not receive treatment. Each subject had 1 control sample (tissue that was taken from an area where no treatment was received), and 1 treatment sample (tissue taken from an area that had been subjected to the treatment). |
|
|
| Primary | Number of Treatment Samples With Different Levels of Dermis Collagen When Compared to Baseline Samples Taken From the Same Patient | Sections of skin were removed using the punch biopsy technique to render a microscopic diagnosis. Each specimen was preserved with a fixative and then stained using Hemotoxylin & Eosin, Verhoeff and Masson Red/Fast Green and/or nitroblue tetrazolium chloride (NBTC) staining methods. If using Hemotoxylin & Eosin, Verhoeff and Masson Red/Fast Green staining, samples were assessed and evaluated by the amount of collagen. If using NBTC staining, samples were assessed and evaluated to differentiate between the blue-stained viable cells and the unstained thermally damaged cells. The samples were examined by a qualified pathologist. The visual changes between the treated samples and the control samples were examined, with no typical unit of measure used to quantify the difference. Simply, control and treatment images were compared to each other with a qualitative analysis of the changes. The number of samples with different levels of collagen (control compared to treatment) is reported. | Posted | Number | biopsy samples | 1 Week (7-10 days) Post Baseline | biopsy samples | biopsy samples |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 4 |
| 7 |
| EG001 | Control Flank | Subjects receive 1 biopsy sample on the contralateral side, where they did not receive treatment. | 0 | 7 | 0 | 7 | 4 | 7 |
| Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Scabbing | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |