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Safety Needle

V Needle AV Fistula Set for Kidney Failure (Clinic-SAVER Trial)

N/A
Waitlist Available
Led By Wesley Calhoun, MD
Research Sponsored by Hemotek Medical Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks (time required to complete all control and experimental cannulations per patient)
Awards & highlights

Clinic-SAVER Trial Summary

This trial is testing a new safety needle to see if it works and is safe to use during hemodialysis.

Eligible Conditions
  • Kidney Failure

Clinic-SAVER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks (time required to complete all control and experimental cannulations per patient)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks (time required to complete all control and experimental cannulations per patient) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of successful hemodialysis sessions with the Hemotek device.
Secondary outcome measures
Hemodialysis
Clinician's ability to cannulate fistula for each hemodialysis session
Machine alarm rate (blood alarms only) during hemodialysis therapy sessions, including false alarms.

Clinic-SAVER Trial Design

1Treatment groups
Experimental Treatment
Group I: Standard of Care vs. V Needle Performance AssessmentExperimental Treatment1 Intervention
Subjects will undergo three dialysis sessions using standard of care needles (control) and results will be compare to 6 dialysis sessions using the V Needle (experimental).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
V Needle AV Fistula Set
2022
N/A
~20

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Who is running the clinical trial?

Hemotek Medical IncLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,059 Total Patients Enrolled
10 Trials studying Kidney Failure
10,720 Patients Enrolled for Kidney Failure
Wesley Calhoun, MDPrincipal InvestigatorDavita Clinical Research

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity to take part in this scientific investigation?

"According to clinicaltrials.gov, this particular study is not currently recruiting patients; the trial was published on September 1st and last amended on August 5th 2022. Despite that, there are still a considerable number of other medical experiments actively seeking participants at this time - namely 587."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis
2022. "Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05493423.
~6 spots leftby Apr 2025
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