Product Design Clinical Performance Study of sc2Wear Furosemide Combination Product

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

Timeline

Start

2016-07

Primary completion

2016-11

Completion

2016-11

Drugs

Indications