Pilot Study for First Clinical Use of sc2Wear Furosemide Combination Product

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 27
• Participant gender: Both

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: scPharmaceuticals, Inc.
• Treatments: Furosemide
• Last Updated: 2016-08-26

Criteria

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 participate in the study.

5. If Subject is on oral diuretic, willing to suspend the oral furosemide or other loop diuretic treatment on the day of treatment (use of oral diuretic within 8 hours of start of treatment is not recommended)

6. If Subject has significant body hair on the abdomen, willing to clip or shave the area where the device will be placed prior to treatment.

7. Has the ability to understand the requirements of the study, and is willing to comply with all study procedures.

Exclusion Criteria:

1. Contraindication to furosemide.

2. History of chronic skin conditions requiring medical therapy.

3. Skin reaction to medical adhesives or history of poor skin adherence of adhesives.

4. Any local abdominal skin condition on the day of treatment i.e. sunburn, rash, eczema, etc.

5. Diabetic patients currently using an insulin pump and/or interstitial glucose monitors.

6. Clinically significant abnormalities at Screening in safety laboratory tests.

7. Hypokalemia - Potassium of < 3.6 mmol/L.

8. Systolic BP (SBP) < 90 mm Hg.

9. Temperature > 38°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment.

10. History of major abdominal surgery affecting the site of device placement.

11. Participation in another trial, within 30 days prior to Screening.

12. History of hepatitis B, hepatitis C, or HIV

13. History of current or recent alcohol abuse.

14. Female subject who is pregnant or lactating.

15. Any surgical or medical condition that in the opinion of the Investigator may interfere with participation in the study or that may affect the outcome of the study.