Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02804282 | Product Design Clinical Performance Study of sc2Wear Furosemide Combination Product | PHASE3 | COMPLETED | 74 | — | — | Jul 1, 2016 | Nov 1, 2016 | Jun 27, 2018 | - | — |
| NCT02804035 | Pilot Study for First Clinical Use of sc2Wear Furosemide Combination Product | PHASE2 | COMPLETED | 27 | — | — | Jul 1, 2016 | Aug 1, 2016 | Oct 16, 2017 | - | — |
Freedom from failures leading to infusion errors.
| Arm | Type | Description |
|---|---|---|
| sc2Wear Furosemide Combination Product | EXPERIMENTAL | Drug-device combination product of buffered furosemide injection, (Furosemide Injection Solution), 8 mg/mL, and patch pump (sc2Wear Furosemide Pump) for subcutaneous administration of 80 mg dose delivered over 5 hours. |
| Name | Type | Description |
|---|---|---|
| sc2Wear Furosemide | COMBINATION_PRODUCT | Drug-device combination product of buffered furosemide injection, (Furosemide Injection Solution), 8 mg/mL, and patch pump (sc2Wear Furosemide Pump) |
Inclusion Criteria: 1. An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities. 2. Male and female Subjects ≥18 years of age 3. New York Heart Association (NYHA) Class II-IV Heart Failure. 4. In the opinion of the Investigator, able to...