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Clinical Trials/CTRI/2018/02/011882
CTRI/2018/02/011882
Not yet recruiting
未知

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

Renalyx Health Systems Pvt Ltd0 sites0 target enrollmentTBD
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Renalyx Health Systems Pvt Ltd
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Renalyx Health Systems Pvt Ltd

Eligibility Criteria

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Not specified

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