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This is a prospective, open label, multi-center clinical study to collect additional data and imaging for the ViaSure device.The intended use of the ViaSure device used in this study is to assess the usability and tissue response to shock wave treatment.
Up to 50 subjects will be enrolled at 2 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments with the study device. Follow up visits may occur 30 and 90 days post last treatment visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shockwave Device | Experimental | The Shockwave device will be used on multiple areas of the body for the purpose of treating connective tissue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shockwave Treatment | Device | Self-controlled, single-arm group using the Shockwave device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| # of Subjects With Altered Gene Expression | Subjects had their gene expression relative to their own baseline samples analyzed using nSolver 4.0 software, and this was done 14 days post treatment. | 14 days post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Civiok | Cynosure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cynosure, Inc. | Westford | Massachusetts | 01886 | 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 | Shockwave Device | The Shockwave device will be used on multiple areas of the body for the purpose of treating connective tissue. Shockwave Treatment: Self-controlled, single-arm group using the Shockwave device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Shockwave Device | The Shockwave device will be used on multiple areas of the body for the purpose of treating connective tissue. Shockwave Treatment: Self-controlled, single-arm group using the Shockwave 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 | # of Subjects With Altered Gene Expression | Subjects had their gene expression relative to their own baseline samples analyzed using nSolver 4.0 software, and this was done 14 days post treatment. | 1 subject did not have their 14 day sample analyzed. | Posted | Count of Participants | Participants | 14 days post treatment |
|
|
Subjects had their adverse events tracked from the beginning of the study to 14 days 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 | Shockwave Device | The Shockwave device will be used on multiple areas of the body for the purpose of treating connective tissue. Shockwave Treatment: Self-controlled, single-arm group using the Shockwave device. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Trimper | Cynosure | (978) 256-4200 | 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 | Apr 7, 2021 | May 1, 2023 | Prot_SAP_000.pdf |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| FitzPatrick Skin Type | Fitzpatrick Skin Types range from I-VI, with I being low melanin content (lighter skin), and VI being high melanin content (darker skin). The reference provided in the references section gives more details if needed. | Count of Participants | Participants |
|
| Participants |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.