Clinical Safety and Efficacy Testing Of The First Indian Hemodialysis Device.

Renalyx Health Systems Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Patient willing and competent to sign the approved informed consent.
•2.Patient must be at least 21 years of age or older.
•3.Patient must weigh between 40 and 100kg, inclusive.
•4.Patient must have End Stage Renal Disease and currently undergoing consistent intermittent HD at least 2 times a week for at least 3 months prior to being enrolled.
•5.Vascular access must be through a functioning arteriovenous fistula (AVF) with no thrombolytic therapy or clotting of the AVF within the past 4 weeks.
•6.Willing to comply with the requirements of experimental treatment with the follow-up after 24 hours.
•7.Expected survival of no less than 6 months.
•8.Consent to allow review of their medical records by the investigators, and monitors.
•9.Hemoglobin level greater than or equal to 9.0 g per dL prior to hemodialysis treatment.

•1.Anticipating or scheduled for a living related donor kidney transplant in less than 2 months.
•2.History (within the 12 weeks prior to the study) of cardiovascular events including.
•Unstable angina
•Myocardial Infarction
•3.Clinical Significant Arrhythmia.
•4.Life threatening arrhythmia within the past 30 days.
•5.Severe intra-dialytic hypotension within the last 30 days.
•6.Shock within the last 30 days.
•7. Hemodynamic instability as demonstrated by repeated episodes of hypotension or hypertension requiring intervention by dialysis personnel or representing a present hazard to the patient.
•8.Seizure disorder requiring active treatment for a seizure episode during the last 6 months.
•9.Major Surgery (excluding vascular access surgery) within the past 30 days.
•10.Currently receiving intravenous antibiotic therapy for systemic infection.
•11. Clinical evidence of metastatic malignancy, receiving radiation or chemotherapy, within the past 365 days.
•12.Active bleeding

发起方

Renalyx Health Systems Pvt Ltd