Product Design Clinical Performance Study of sc2Wear Furosemide Combination Product
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|ClinicalTrials.gov Identifier: NCT02804282|
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : June 27, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Combination Product: sc2Wear Furosemide||Phase 3|
This study will be an open label, single-dose study to evaluate product design clinical performance of a to-be-marketed drug-device combination product (sc2WearTM Furosemide Combination Product) in up to 70 adult male and female Subjects previously diagnosed with mild to advanced heart failure (NYHA Class II-IV). The study was designed and powered to achieve "95/95" performance testing. Methodology: Each Subject will complete Screening, Treatment, and Follow-Up Phases on an outpatient basis. During the Screening Phase, all Subjects who sign the informed consent form and satisfy the inclusion/exclusion criteria will be enrolled into the trial. Drug administration may start on the day of enrollment or be scheduled within 3 days of completion of Screening assessments. However, if the treatment visit doesn't occur within 3 days of initial screening, subjects may be rescreened and treated within 3 days of rescreening. The Treatment Phase comprises a preprogrammed bi-phasic 5 hour drug administration. Treatment Day observations will commence with pre-placement assessments and continue until after device removal. Device preparation, placement and removal will be performed by study staff in accordance with product instructions of use. Removal will occur within 3 hours of completion of drug delivery (8 hours of start of administration). Subjects will return 5-7 days after the Treatment Day for a post treatment follow-up and photography.
Blood samples will be obtained for the measurement of plasma furosemide levels prior to start of the administration and once during the plateau phase (1-5 hours following activation). After preparation of the skin the device will be placed on the upper abdominal area by clinical study staff. Subjects are advised to avoid strenuous physical activity or activities that could expose the device to moisture such as swimming, bathing or showering. Participants will be informed that marked diuresis may ensue after activation, and that they should avoid travel, operating a vehicle or other situations without immediate access to bathroom facilities. For this study, up to 70 unique reusable components (Activator) will be used. Likewise, up to 70 single-use units (Cartridge) will be used. Following removal from the skin, the assembled device will be inspected and photographed by the site staff. The used device (assembled Cartridge and Activator) will be placed in a sealed container and returned for further inspection and measurement of residual volume in the device reservoir by a qualified laboratory.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Study to Evaluate Product Design Clinical Performance of a To-Be-Marketed Drug-Device Combination Product (sc2Wear Furosemide Combination Product) in Subjects With Chronic Heart Failure|
|Study Start Date :||July 2016|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
Experimental: sc2Wear Furosemide Combination Product
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.
Combination Product: sc2Wear Furosemide
Drug-device combination product of buffered furosemide injection, (Furosemide Injection Solution), 8 mg/mL, and patch pump (sc2Wear Furosemide Pump)
- Absence of Major Product Failure [ Time Frame: 1-5 hours ]Freedom from failures leading to infusion errors.
- Local Pain Tolerance [ Time Frame: 1-5 hours ]Subject-reported pain using 11 point numeric rating scale of 0 to 10.
- Local Skin Tolerance [ Time Frame: 1-8 days ]Adhesive site skin inspection for erythema, edema and other local reactions using 8 point scale.
- Incidence of treatment-emergent Adverse Events and Serious Adverse Events [ Time Frame: 1-8 days ]