Product Design Clinical Performance Study of sc2Wear Furosemide Combination Product
Status:
Not yet recruiting
Trial end date:
0000-00-00
Target enrollment:
Participant gender:
Summary
The proposed single-dose study aims to evaluate the product design clinical performance of
the to-be-marketed drug-device combination product, the sc2Wear Furosemide Combination
Product, in adult Subjects previously diagnosed with mild to advanced heart failure.
The study drug formulation is a buffered Furosemide Injection Solution, 8 mg/mL, (total dose
equals 80 mg/mL) administered subcutaneously for a total of 5 hours. The study device is the
sc2Wear Furosemide Pump adhered to the body using medical grade adhesive.
The objectives of this study are:
- To demonstrate that the to-be-marketed drug-device combination product performs as
intended and delivers 80 mg of Furosemide subcutaneously in the abdominal area
- To assess safety and local tolerance of the drug-device combination product