Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT02804035
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02804035
Study Brief:
Protocol Section:
NCT02804035