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Pilot Study for First Clinical Use of sc2Wear Furosemide Combination Product

NCT02804035 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2017-10-16

No results posted yet for this study

Summary

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

Conditions

Interventions

COMBINATION_PRODUCT

sc2Wear Furosemide

Drug-device combination product of buffered furosemide injection, (Furosemide Injection Solution), 8 mg/mL, and patch pump (sc2Wear Furosemide Pump)

Sponsors & Collaborators

  • scPharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2016-08-31
Completion
2016-08-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02804035 on ClinicalTrials.gov