Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis

Study Overview
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Brief Summary
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This study is a prospective, multi-center, single-arm study with subjects acting as their own control designed to confirm the safety, performance, and usability of the V Needle, a new safety needle for use during in-clinic hemodialysis that is designed to automatically generate a partial occlusion of the internal fluid path and trigger the hemodialysis machine to alarm and shut off if a complete dislodgement of the venous needle from the arm inadvertently occurs.

Detailed Description
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In patients undergoing hemodialysis for the treatment of end-stage renal disease, Venous Needle Dislodgement (VND) is a rare, but potentially fatal situation in which the needle delivering a patient's blood back to the body after filtration by a dialysis machine becomes inadvertently disconnected from the patient. Hemotek Medical Inc. has developed the V Needle, a venous needle return that is designed to reduce patient risk from exsanguination-related injury or death. This clinical study will serve as a confirmatory study to gain FDA marketing clearance of the Hemotek V Needle system in the clinical setting. During this study, the ability of the V Needle to successfully deliver appropriate hemodialysis therapy per the facility's guidelines will be assessed. It will also be used to determine if the V Needle triggers false blood alarms under normal operating conditions. This study will also be used to demonstrate the V Needle meets effective usability criteria. Rates of adverse events and ability to complete the hemodialysis session will be compared to the rates recorded using commercially available devices during the hemodialysis sessions prior to the use of the Hemotek V Needle. The study is an open-label, non-randomized, single arm, multi-center trial with subject's serving as their own control. For the first three (3) control sessions, subjects will undergo usual hemodialysis sessions with a commercially available device. For the remaining six (6) sessions, subjects will be cannulated with a V Needle in place of a usual venous line AV fistula set. The hemodialysis sessions will be conducted in the clinic. Subjects will be observed by a clinician for the duration of each session. Clinicians will monitor the session for any abnormal disruptions, therapy interruptions, and/or adverse events, including hemolysis, due to V Needle presence. All machine blood alarms, therapy interruptions, and/or partial or complete needle dislodgements will be recorded and immediately corrected. A clinician will perform cannulation. Cannulation site and surrounding tissue will be examined by the nurse and assessed for any locally induced trauma before and after treatment. A survey will be completed by the clinicians and patients to assess usability, comfort, and feelings of safety of the V Needle.

Official Title
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Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis: Clinic-SAVER

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Device: V Needle AV Fistula Set


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with end-stage renal disease receiving chronic hemodialysis in a clinical setting. Subjects must be able to receive hemodialysis with the Hemotek 15-gauge, 1 inch length V Needle, with 12 inch tubing. Age greater than or equal to 22 years old at screening. Vascular access via a mature arteriovenous (AV) fistula or graft in the arm and determined to be adequate for a chronic hemodialysis therapy. AV fistula has already been demonstrated to adequately permit one or more hemodialysis sessions. Subject prescribed blood flow rates between 200 ml/min and 450 ml/min In women with child-bearing potential, negative urine or serum pregnancy test at Screening. Subject able to communicate effectively with investigative staff, competent and willing to give written informed consent, and able to comply with entire study procedures. Hemoglobin ≥9 g/dL (consistent with KDOQI guidelines) Normal platelet count (≥150,000 /mm3) International Normalized Ratio (INR) ≤ 1.5 Exclusion Criteria: Subjects receiving chronic hemodialysis with a vascular catheter. Subjects with vascular access that is determined by the clinician to be unacceptable for a hemodialysis procedure. Patients with a bleeding diathesis Patients receiving anti-coagulants Previous vascular access surgery (≤30 days from study entry) or planned access surgery Known hypersensitivity to any imaging agents (e.g., contrast) that may be required during the study period Patients with confirmed vasculitis Vascular access infection or systemic active infection within 30 days of study entry Life expectancy less than 12 months Planned renal transplantation or planned conversion to peritoneal dialysis Subjects with any condition determined by the investigator that precludes them from safely participating in the study.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard of Care vs. V Needle Performance Assessment<br>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). | Device: V Needle AV Fistula Set<br>* Hemotek Medical Inc. has developed the V Needle, a new AV fistula set for hemodialysis designed to reduce patient risk from exsanguination-related injury or death during therapy. In the event of complete dislodgement of the V Needle from the arm during use, the V Needle is designed to activate, creating high line pressure designed to generate an automated dialysis machine blood pump shut down.<br>* Other names: V Needle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of successful hemodialysis sessions with the Hemotek device. | A successful hemodialysis session is one in which the physician's dialysis prescription has been appropriately delivered. There are only two options for results: successful or unsuccessful. Success rates will be calculated for 3 control sessions using standard of care needles and compared with the average success rate determined from 6 experimental V Needle sessions. | 3 weeks (time required to complete all control and experimental dialysis sessions per patient) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Machine alarm rate (blood alarms only) during hemodialysis therapy sessions, including false alarms. | The hemodialysis machine alarm rate will be monitored per session and then averaged and compared for three control sessions using standard of care needles and then again for six experimental V Needle sessions. | 3 weeks (time required to complete all control and experimental dialysis sessions per patient) | 
| Achieved blood flow rate during hemodialysis therapy sessions | Variations of the blood flow rate will be monitored to determine if the achieved blood flow rate during a given session is within 75% of the prescribed blood flow rate. Assessments will be determined for three control sessions using standard of care needles and for six V Needle sessions. | 3 weeks (time required to complete all control and experimental dialysis sessions per patient) | 
| Clinician's ability to cannulate fistula for each hemodialysis session | The clinician will self-report if the fistula was successfully cannulated (a yes or no metric) for three control sessions using standard of care needles and for six V Needle sessions. | 3 weeks (time required to complete all control and experimental cannulations per patient) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, dialysis, dislodgement, venous needle, venous needle dislodgement, AV fistula set