End Stage Renal Disease
Conditions
Keywords
hemodialysis, dialysis, dislodgement, venous needle, venous needle dislodgement, AV fistula set
Brief summary
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
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.
Interventions
DEVICEV 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Hemotek Medical Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Successful Hemodialysis Sessions | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| False Alarms Per Session (as a % of All Venous Alarms Per Same Session) | 3 weeks (time required to complete all control and test dialysis sessions per patient) | Overall false alarm rate per hemodialysis session as determined as a percentage of all venous alarms. |
| Venous Alarm Rate (All) Per Session | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | Rate of venous alarms per hemodialysis session |
| % All (False) Alarms Related to V Needle Footplate Opening Inappropriately | 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 during each hemodialysis session |
| % All Alarms Related to Venous Needle | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | % of all alarms related to Venous needle per hemodialysis session |
| % Hemodialysis Sessions Requiring a Change to Blood Flow Rate Setting During Therapy | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | Percentage of the hemodialyis sessions during which the clinical staff was required to change the original blood flow rate setting during therapy sessions |
| Mean Venous Pressure (in mm Hg) Per Hemodialyis 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 Venous Pressure (in mm Hg) per hemodialysis session for subjects dialyzing at a flow rate of 400 mL/min |
| Machine Alarm Rate (Blood Alarms Only) During Hemodialysis Therapy Sessions, Including False Alarms. | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | 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. |
| Mean Transmembrane Pressure (in mm Hg) Per 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 hemodialysis session for subjects dialyzing at 400 mL/min |
| Mean Transmembrane Pressure (mm Hg) Per 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 Transmembrane Pressure (mm Hg) per hemodialysis session for subjects dialyzing at 450 mL/min |
| Mean Arterial Pressure (in mm Hg) Per Session for Subjects Dialyzing at a Flow Rate 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 (mm Hg) per each session for subjects dialyzing at a flow rate of 400 mL/min |
| Mean Arterial Pressure (in mm Hg) Per Session for Subjects Dialyzing at a Flow Rate 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 (mm Hg) per session for those subjects dialyzing at a flow rate of 450 mL/min |
| % Hemodialysis Sessions Where 'Achieved' Blood Flow Rate is Within 75% of 'Prescribed' Blood Flow Rate | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | 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. |
| % Sessions Where Clinician Was Able to Successfully Cannulate Fistula | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | 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. |
| Mean Venous Pressure (in mm Hg) Per Hemodialyis 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 Venous Pressure (in mm Hg\_) per hemodialysis session for subjects dialyzing at a flow rate of 450 mL/min |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from patients receiving hemodialysis three times per week at one of two Davita dialysis clinics in San Antonio, TX. 15 subjects total were evaluated and each subject served as their own control. So 15 subjects each had three control sessions followed by six V Needle sessions..
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care vs. V Needle Performance Assessment Subjects serve as their own controls in this study. They will undergo three dialysis sessions using standard of care needles (control sessions) and those results will be compared to 6 dialysis sessions using the V Needle (test sessions). THEREFORE, WE DO NOT USE A BASELINE MEASURE HERE BUT INSTEAD INCLUDE A 'CONTROL ARM' IN THE OUTCOME MEASURES SECTIONS. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Standard of Care vs. V Needle Performance Assessment |
|---|---|
| Age, Continuous | 52.7 years STANDARD_DEVIATION 10.22 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 15 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 1 / 15 | 2 / 15 |
| serious Total, serious adverse events | 0 / 15 | 1 / 15 |
Outcome results
Primary
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.
Time frame: 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
Population: Study subjects who meet eligibility criteria at each site
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Device | Percentage of Successful Hemodialysis Sessions | 100 percentage of successful sessions |
| Test Device | Percentage of Successful Hemodialysis Sessions | 98.9 percentage of successful sessions |
p-value: 0.008Farrington-Manning
p-value: 0.002Equivalence Test with paired data
Other Pre-specified
% All Alarms Related to Venous Needle
% of all alarms related to Venous needle per hemodialysis session
Time frame: 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Device | % All Alarms Related to Venous Needle | 12 % of all alarms related to venous needle |
| Test Device | % All Alarms Related to Venous Needle | 18 % of all alarms related to venous needle |
p-value: 0.197t-test, 2 sided
Other Pre-specified
% All (False) Alarms Related to V Needle Footplate Opening Inappropriately
% All (false) Alarms Related to V Needle footplate opening inappropriately during each hemodialysis session
Time frame: 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
Population: There are 0 units analyzed in the control arm because the control device does not have a protective footplate to assess.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Device | % All (False) Alarms Related to V Needle Footplate Opening Inappropriately | 0 % All (false) Alarms Related to V Needle |
p-value: 0.84t-test, 2 sided
Other Pre-specified
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.
Time frame: 3 weeks (time required to complete all control and test dialysis sessions per patient)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Device | False Alarms Per Session (as a % of All Venous Alarms Per Same Session) | 82 percentage of false alarms |
| Test Device | False Alarms Per Session (as a % of All Venous Alarms Per Same Session) | 83.66 percentage of false alarms |
p-value: 0.84t-test, 2 sided
Other Pre-specified
% 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
Time frame: 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Device | % Hemodialysis Sessions Requiring a Change to Blood Flow Rate Setting During Therapy | 6.67 percentage of hemodialysis sessions |
| Test Device | % Hemodialysis Sessions Requiring a Change to Blood Flow Rate Setting During Therapy | 3.33 percentage of hemodialysis sessions |
p-value: 0.424t-test, 2 sided
Other Pre-specified
% 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.
Time frame: 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
Population: Study subjects who meet eligibility criteria at each site
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Device | % Hemodialysis Sessions Where 'Achieved' Blood Flow Rate is Within 75% of 'Prescribed' Blood Flow Rate | 95.6 percentage of sessions |
| Test Device | % Hemodialysis Sessions Where 'Achieved' Blood Flow Rate is Within 75% of 'Prescribed' Blood Flow Rate | 98.9 percentage of sessions |
p-value: 0.307t-test, 2 sided
Other Pre-specified
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.
Time frame: 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
Population: The same 15 subjects served as their own controls.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Device | Machine Alarm Rate (Blood Alarms Only) During Hemodialysis Therapy Sessions, Including False Alarms. | 1.11 alarms/session | Standard Deviation 0.25 |
| Test Device | Machine Alarm Rate (Blood Alarms Only) During Hemodialysis Therapy Sessions, Including False Alarms. | 1.92 alarms/session | Standard Deviation 0.51 |
p-value: 0t-test, 2 sided
Other Pre-specified
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
Time frame: 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Device | Mean Arterial Pressure (in mm Hg) Per Session for Subjects Dialyzing at a Flow Rate 400 mL/Min | -167 mm Hg/session | Standard Deviation 32 |
| Test Device | Mean Arterial Pressure (in mm Hg) Per Session for Subjects Dialyzing at a Flow Rate 400 mL/Min | -175 mm Hg/session | Standard Deviation 36 |
p-value: 0.211t-test, 2 sided
Other Pre-specified
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
Time frame: 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Device | Mean Arterial Pressure (in mm Hg) Per Session for Subjects Dialyzing at a Flow Rate 450 mL/Min | -197 mm Hg/session | Standard Deviation 37 |
| Test Device | Mean Arterial Pressure (in mm Hg) Per Session for Subjects Dialyzing at a Flow Rate 450 mL/Min | -199 mm Hg/session | Standard Deviation 29 |
p-value: 0.804t-test, 2 sided
Other Pre-specified
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
Time frame: 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Device | Mean Transmembrane Pressure (in mm Hg) Per Session for Subjects Dialyzing at 400 mL/Min | 48 mm Hg/session | Standard Deviation 17 |
| Test Device | Mean Transmembrane Pressure (in mm Hg) Per Session for Subjects Dialyzing at 400 mL/Min | 48 mm Hg/session | Standard Deviation 16 |
p-value: 0.57t-test, 2 sided
Other Pre-specified
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
Time frame: 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Device | Mean Transmembrane Pressure (mm Hg) Per Session for Subjects Dialyzing at 450 mL/Min | 43 mm Hg/session | Standard Deviation 14 |
| Test Device | Mean Transmembrane Pressure (mm Hg) Per Session for Subjects Dialyzing at 450 mL/Min | 44 mm Hg/session | Standard Deviation 13 |
p-value: 0t-test, 2 sided
Other Pre-specified
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
Time frame: 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Device | Mean Venous Pressure (in mm Hg) Per Hemodialyis Session for Subjects Dialyzing at 400 mL/Min | 179 mm Hg/session | Standard Deviation 31 |
| Test Device | Mean Venous Pressure (in mm Hg) Per Hemodialyis Session for Subjects Dialyzing at 400 mL/Min | 208 mm Hg/session | Standard Deviation 37 |
p-value: 0t-test, 2 sided
Other Pre-specified
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
Time frame: 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Device | Mean Venous Pressure (in mm Hg) Per Hemodialyis Session for Subjects Dialyzing at 450 mL/Min | 213 mm Hg/session | Standard Deviation 30 |
| Test Device | Mean Venous Pressure (in mm Hg) Per Hemodialyis Session for Subjects Dialyzing at 450 mL/Min | 247 mm Hg/session | Standard Deviation 35 |
p-value: 0t-test, 2 sided
Other Pre-specified
% 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.
Time frame: 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
Population: Study subjects who meet eligibility criteria at each site
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Device | % Sessions Where Clinician Was Able to Successfully Cannulate Fistula | 100 percentage of hemodialysis sessions |
| Test Device | % Sessions Where Clinician Was Able to Successfully Cannulate Fistula | 98.9 percentage of hemodialysis sessions |
p-value: 0.315t-test, 2 sided
Other Pre-specified
Venous Alarm Rate (All) Per Session
Rate of venous alarms per hemodialysis session
Time frame: 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Device | Venous Alarm Rate (All) Per Session | 0.14 venous alarms/session | Standard Deviation 0.43 |
| Test Device | Venous Alarm Rate (All) Per Session | 0.36 venous alarms/session | Standard Deviation 0.38 |
p-value: 0.132t-test, 2 sided