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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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To evaluate the safety of the prototype Compression Device in subjects with Oedema
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Profile A | Placebo Comparator | Device worn; no pressure given (placebo) |
|
| Profile B | Active Comparator | Foot at 30mm Hg, Gaiter at 40 mm Hg, mid-calf at 30 mm Hg and upper cuff at 20mm Hg |
|
| Profile C | Active Comparator | Foot at 20mm Hg, Gaiter at 30 mm Hg, mid-calf at 20 mm Hg and upper cuff at 10mm Hg |
|
| Profile D | Active Comparator | Foot at 10mm Hg, Gaiter at 20 mm Hg, mid-calf at 10 mm Hg and upper cuff at 0mm Hg |
|
| Profile E | Active Comparator | Foot at 30mm Hg, Gaiter at 40 mm Hg, mid-calf at 40 mm Hg and upper cuff at 40mm Hg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prototype device (unnamed) worn-no pressure given (placebo) from inflatable cuffs | Device |
| ||
| Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs |
| Measure | Description | Time Frame |
|---|---|---|
| The nature and incidence of adverse events | ||
| Volume reduction | ||
| Oedema reduction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Vanscheidt | Hautarzt Phlebologe Allergologe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hautarzt Phlebologe Allergologe | Freiburg im Breisgau | Germany |
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| Profile F | Active Comparator | Foot at 20mm Hg, Gaiter at 30 mm Hg, mid-calf at 30 mm Hg and upper cuff at 30mm Hg |
|
| Profile G | Active Comparator | Foot at 10mm Hg, Gaiter at 20 mm Hg, mid-calf at 20 mm Hg and upper cuff at 20mm Hg |
|
| Device |
|
| Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs | Device |
|
| Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs | Device |
|
| Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs | Device |
|
| Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs | Device |
|
| Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs | Device |
|
| ID | Term |
|---|---|
| D004487 | Edema |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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