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:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT02280005
Eligibility Criteria:
Inclusion Criteria:
* Patient willing and competent to sign the approved informed consent.
* Patient must be at least 21 years of age or older.\*
* Patient must weigh between 45 and 100kg, inclusive.\*
* Patient must have End Stage Renal Disease and currently undergoing consistent intermittent HD at least 3 times a week for at least 3 months prior to being enrolled.\*
* Vascular access must be through a functioning double lumen catheter with no thrombolytic therapy or clotting of the catheter within the past 4 weeks.\*
* Willing to comply with the requirements of experimental treatment with the WAK for up to 24 hours.
* Expected survival of no less than 6 months.\*
* Consent to allow review of their medical records by the investigators, and monitors.
* Fluency in English
* Hemoglobin level ≥ 9.0 g/dL prior to WAK treatment
Exclusion Criteria:
* • Anticipating or scheduled for a living related donor kidney transplant in less than 2 months.\*\*
* History (within the 12 weeks prior to the study) of cardiovascular events including:\*
* Unstable angina
* Myocardial Infarction
* Stroke
* Clinical Significant Arrhythmia
* Life threatening arrhythmia within the past 30 days\*
* Severe intradialytic hypotension within the last 30 days\*
* Shock within the last 30 days\*
* Hemodynamic instability as demonstrated by repeated episodes of hypotension or hypertension requiring intervention by dialysis personnel or representing a present hazard to the patient\*
* Seizure disorder requiring active treatment for a seizure episode during the last 6 months\*
* Major Surgery (excluding vascular access surgery) within the past 30 days \*
* Currently receiving intravenous antibiotic therapy for systemic infection\*
* Clinical evidence of metastatic malignancy, receiving radiation or chemotherapy, within the past 365 days\*
* Active bleeding\*
* Hematological disease (e.g. malignancies, hemolytic anemia, thrombocytopenia), and other conditions that may interfere of confuse the data obtained from this trial.\*
* Current enrollment in another investigational device or drug trial.\*\*
* Subject is pregnant (e.g., positive HCG test) or is breast feeding.
* Subject has any disorder (excluding illiteracy or visual impairment) that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures.\*
* Allergy to heparin or ethylene oxide.\*
* Hypertension deemed uncontrolled, at the discretion of the investigator, within the past 30 days.\*
* Has an implantable electronic device (e.g. pacemaker)\*
* As documented in patient medical history (see attached). \*\*Patient self-report.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02280005
Study Brief:
Protocol Section:
NCT02280005