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

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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Device: V Needle AV Fistula Set

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Davita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects with end-stage renal disease receiving chronic hemodialysis in a clinical setting.
2. Subjects must be able to receive hemodialysis with the Hemotek 15-gauge, 1 inch length V Needle, with 12 inch tubing.
3. Age greater than or equal to 22 years old at screening.
4. Vascular access via a mature arteriovenous (AV) fistula or graft in the arm and determined to be adequate for a chronic hemodialysis therapy.
5. AV fistula has already been demonstrated to adequately permit one or more hemodialysis sessions.
6. Subject prescribed blood flow rates between 200 ml/min and 450 ml/min
7. In women with child-bearing potential, negative urine or serum pregnancy test at Screening.
8. Subject able to communicate effectively with investigative staff, competent and willing to give written informed consent, and able to comply with entire study procedures.
9. Hemoglobin ≥9 g/dL (consistent with KDOQI guidelines)
10. Normal platelet count (≥150,000 /mm3)
11. International Normalized Ratio (INR) ≤ 1.5

Exclusion Criteria:

1. Subjects receiving chronic hemodialysis with a vascular catheter.
2. Subjects with vascular access that is determined by the clinician to be unacceptable for a hemodialysis procedure.
3. Patients with a bleeding diathesis
4. Patients receiving anti-coagulants
5. Previous vascular access surgery (≤30 days from study entry) or planned access surgery
6. Known hypersensitivity to any imaging agents (e.g., contrast) that may be required during the study period
7. Patients with confirmed vasculitis
8. Vascular access infection or systemic active infection within 30 days of study entry
9. Life expectancy less than 12 months
10. Planned renal transplantation or planned conversion to peritoneal dialysis
11. Subjects with any condition determined by the investigator that precludes them from safely participating in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Standard of Care vs. V Needle Performance Assessment; 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; 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.; Other Names: V Needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Successful Hemodialysis Sessions	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 total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject

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)

Other 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 total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
False Alarms Per Session (as a % of All Venous Alarms Per Same Session)	Overall false alarm rate per hemodialysis session as determined as a percentage of all venous alarms.	3 weeks (time required to complete all control and test dialysis sessions per patient)
Venous Alarm Rate (All) Per Session	Rate of venous alarms per hemodialysis session	3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
% All (False) Alarms Related to V Needle Footplate Opening Inappropriately	% All (false) Alarms Related to V Needle footplate opening inappropriately during each hemodialysis session	3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
% All Alarms Related to Venous Needle	% of all alarms related to Venous needle per hemodialysis session	3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
% Hemodialysis Sessions Requiring a Change to Blood Flow Rate Setting During Therapy	Percentage of the hemodialyis sessions during which the clinical staff was required to change the original blood flow rate setting during therapy sessions	3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
Mean Venous Pressure (in mm Hg) Per Hemodialyis Session for Subjects Dialyzing at 400 mL/Min	Mean Venous Pressure (in mm Hg) per hemodialysis session for subjects dialyzing at a flow rate of 400 mL/min	3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
Mean Venous Pressure (in mm Hg) Per Hemodialyis Session for Subjects Dialyzing at 450 mL/Min	Mean Venous Pressure (in mm Hg_) per hemodialysis session for subjects dialyzing at a flow rate of 450 mL/min	3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
Mean Transmembrane Pressure (in mm Hg) Per Session for Subjects Dialyzing at 400 mL/Min	Mean Transmembrane Pressure (mm Hg) per hemodialysis session for subjects dialyzing at 400 mL/min	3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
Mean Transmembrane Pressure (mm Hg) Per Session for Subjects Dialyzing at 450 mL/Min	Mean Transmembrane Pressure (mm Hg) per hemodialysis session for subjects dialyzing at 450 mL/min	3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
Mean Arterial Pressure (in mm Hg) Per Session for Subjects Dialyzing at a Flow Rate 400 mL/Min	Mean Arterial Pressure (mm Hg) per each session for subjects dialyzing at a flow rate of 400 mL/min	3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
Mean Arterial Pressure (in mm Hg) Per Session for Subjects Dialyzing at a Flow Rate 450 mL/Min	Mean Arterial Pressure (mm Hg) per session for those subjects dialyzing at a flow rate of 450 mL/min	3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
% Hemodialysis Sessions Where 'Achieved' Blood Flow Rate is Within 75% of 'Prescribed' Blood Flow Rate	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 total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
% Sessions Where Clinician Was Able to Successfully Cannulate Fistula	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 test sessions.	3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject

Collaborators and Investigators

• Sponsor: Hemotek Medical Inc
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Wesley Calhoun, MD, Davita Clinical Research; Principal Investigator: Tahira Alves, MD, Davita Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Actual): July 10, 2023
• Study Completion (Actual): July 17, 2023

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: dialysis; hemodialysis; dislodgement; venous needle; venous needle dislodgement; AV fistula set
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: CIP 001; 5R44DK101253 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes