Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A simulated clinical use testing on the DropSafe safety pen needle
This study aims to evaluate the safety of the use of DropSafe safety pen needle in the prevention of needle stick injuries (NSI) and to evaluate the user's satisfaction with regards to the handling characteristics of the product.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| simulation of injection | Experimental | The evaluator simulated the injection with the DropSafe safety pen needle and a pen injector with a sterile, water-filled cartridge using an orange. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DropSafe safety pen needle | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| The true failure rate of DropSafe safety pen needle. | The failure rate of the safety feature for the DropSafe safety pen needle was estimated using the proportion of devices that fail out of the total tested. Failure was defined as NSI or contact with the needle after injection or non-complete activation of the safety feature. | At time of testing, about an hour |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of use | Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree) | At time of testing, about an hour |
| Ability to follow the instructions for use | Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
1. If in the opinion of the sponsor or MRO, including the observer/monitor, the potential evaluator is not a good candidate for the study, including for reasons such as mental health.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NAMSA | Golden Valley | Minnesota | 55422 | United States | ||
| NAMSA |
Not provided
| ID | Term |
|---|---|
| D016602 | Needlestick Injuries |
| ID | Term |
|---|---|
| D014951 | Wounds, Stab |
| D014950 | Wounds, Penetrating |
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| At time of testing, about an hour |
| Ease of understanding the instructions for use | Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree) | At time of testing, about an hour |
| Problems associated with the device | Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree) | At time of testing, about an hour |
| Minneapolis |
| Minnesota |
| 55426 |
| United States |