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NCT03359161 · ClinicalTrials.gov registry record · Phase 2
Clinical Utility of Subcutaneous Furosemide in Patients Presenting With Early Signs of Fluid Overload
A Phase 2 study, sponsored by Steward St. Elizabeth's Medical Center of Boston.
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT03359161 is a Phase 2 study that was terminated before completion, run by Steward St. Elizabeth's Medical Center of Boston. The registered enrollment target is 9 participants.
The verdict
NCT03359161, a Phase 2 study, was terminated before completion, sponsored by Steward St. Elizabeth's Medical Center of Boston.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
This study will evaluate the usefulness of the subcutaneous administration of a new Lasix formulation. 20 patients will be evaluated in the first phase (pilot phase) and depending on the results, an additional 40 patients will be enrolled (Evaluation Phase). Patients with mild to moderate evidence of fluid overload who present to the cardiology service at St Elizabeth's Medical Center, Brighton, Massachusetts (SEMC) will be included in the study. Patients who qualify for thus study will be sent home with the sc2Wear™ Furosemide Infusor therapy for three days. This is a pump that patients place on their abdomen and it then delivers furosemide to the skin. Participants will be visited at home by a visiting nurse who will give them further teaching on the sc2Wear™ Furosemide Infusor. The visiting nurse will also be responsible for obtaining history (symptoms), physical examination (including inspecting the skin for adverse reactions related to the pump), and laboratory draws, supplementation of electrolytes as needed. Patients will be evaluated by the cardiology service of SEMC within 24 hours of the last dose of the sc2Wear™ Furosemide Infusor. If a patient is found to have satisfactorily responded but requires more therapy, an additional 4 days may be prescribed for total of seven consecutive treatments. If additional units are prescribed, patients will be evaluated by the cardiology service of SEMC within 24 hours of the last dose of the sc2Wear™ Furosemide infusion. Also an additionally, up to three-sc2Wear furosemide at home treatments may be used as authorized by the treating physician in case the patient experiences worsening heart failure within 30-days of enrollment (Rescue Treatment). Participants will be seen in clinic for follow up at 30±3 days after the start of the study for a post treatment.
Interventions
- COMBINATION_PRODUCT sc2Wear Furosemide Infusor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2018-04-05 |
| Est. Completion | 2019-01-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03359161
The ClinicalTrials.gov registry entry for NCT03359161 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Steward St. Elizabeth's Medical Center of Boston, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which sc2Wear Furosemide Infusor is the first listed.
NCT03359161 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03359161 about?
NCT03359161 is a clinical study titled "Clinical Utility of Subcutaneous Furosemide in Patients Presenting With Early Signs of Fluid Overload". This study will evaluate the usefulness of the subcutaneous administration of a new Lasix formulation. 20 patients will be evaluated in the first phase (pilot phase) and depending on the results, an additional 40 patients will be enrolled (Evaluation Phase). Patients with mild to moderate evidence o...
What is the current status of trial NCT03359161?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2018-04-05. Estimated completion is 2019-01-31.
What interventions are being tested in trial NCT03359161?
The interventions under investigation include: sc2Wear Furosemide Infusor (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03359161?
This trial is sponsored by Steward St. Elizabeth's Medical Center of Boston, which has 18 total clinical trials registered on ClinicalTrials.gov.
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