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 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT03072732
Eligibility Criteria:
Inclusion Criteria:
* Men and women at least 21 years of age.
* Is currently scheduled to undergo hemodialysis 3 times per week in a clinic setting and has been on this regimen for at least 3 months.
* For those patients with CHF: were diagnosed with CHF by a qualified provider and show symptomatic signs of New York Heart Association (NYHA) Class II to IV at enrollment.
* Is prescribed a net fluid removal of at least 2.5 L during the hemodialysis session.
* Is willing and able to sign informed consent in English.
Exclusion Criteria:
* Is a female patient with a known pregnancy or is unsure of pregnancy status.
* Has known allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
* Has skin breakdown in areas where device and electrode placement is required.
* Was hospitalized within the 2 weeks prior to enrollment.
* Had intradialytic hypotension requiring administration of intravenous (IV) fluids of ≥250 mL or that resulted in a referral to urgent care, within 2 weeks prior to enrollment.
* Had myocardial infarction, acute coronary syndrome, or stroke within 4 weeks prior to enrollment.
* Has active nephrotic syndrome
* Has severe malnutrition, as diagnosed per a qualified provider.
* Is participating in another clinical trial.
* Has an implanted device that might interfere with the µ-Cor.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03072732
Study Brief:
Protocol Section:
NCT03072732