Pilot Study for First Clinical Use of sc2Wear Furosemide Combination Product
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|ClinicalTrials.gov Identifier: NCT02804035|
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : October 16, 2017
The proposed pilot study aims to gain experience with the first clinical use of the to-be marketed drug-device combination product, the sc2Wear Furosemide Combination Product and to assess methods and procedures for evaluation of product performance.
The objectives of this study are:
- To gain first in man experience of a novel drug-device combination product
- To evaluate the suitability of the methods and procedures for evaluating of the performance of the sc2Wear Pump
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Combination Product: sc2Wear Furosemide||Phase 2|
This study will be an open label, single-dose study to gain experience with first clinical use and to evaluate the suitability of the methods and procedures for evaluation of product performance of a to-be-marketed drug-device combination product (sc2WearTM Furosemide Combination Product) in a minimum of 20 adult male and female subjects previously diagnosed with mild to advanced heart failure (NYHA class II-IV). The study will enroll up to 30 Subjects to ensure a minimum of 20 evaluable Subjects. 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 procedures. 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 procedures and continue until one hour after device removal. Device preparation, placement and removal will be performed by study staff in accordance with product instructions for 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. 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 each Subject, a reusable components (Activator) and a single-use unit (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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label First in Human Use Pilot Study 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 :||August 2016|
|Actual Study Completion Date :||August 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 ]