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The study was terminated by Spiracur. Efforts were made to contact the PI/study team members, but were unsuccessful.
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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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The purpose of this study is to evaluate the safety and efficacy of the Closed-Incision SNaP Device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ciSNaP | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ciSNaP | Device | SNaP disposable, mechanically powered Negative Pressure Wound Therapy System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Complaints About Device Use and Operation | Frequency of complaints about device use and operation | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El Camino Hospital | Mountain View | California | 94040 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ciSNaP | SNaP disposable, mechanically powered Negative Pressure Wound Therapy System |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ciSNaP | SNaP disposable, mechanically powered Negative Pressure Wound Therapy System |
| 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 | Frequency of Complaints About Device Use and Operation | Frequency of complaints about device use and operation | The study was terminated by Spiracur. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available. | Posted | 30 days |
|
|
30 Days
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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 | ciSNaP | SNaP disposable, mechanically powered Negative Pressure Wound Therapy System |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blister | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Global Clinical Development | KCI | 210-255-5595 | jkhart@mmm.com |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 0 |
| 51 |
| 0 |
| 51 |
| 6 |
| 51 |
| Mild surgical infection | Infections and infestations | Non-systematic Assessment |
|
| Congestive Heart Failure exacerbation | Cardiac disorders | Non-systematic Assessment |
|
| Stitch granuloma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Minor dehiscence | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hemarthrosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Lymphocele | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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