Trial Outcomes & Findings for Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis (NCT NCT05493423)

NCT ID: NCT05493423

Last Updated: 2025-02-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
• Results posted on: 2025-02-05

Participant Flow

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..

Participant milestones

Measure	Standard of Care (Control) First, Then V Needle (Experimental) 15 Subjects served as their own controls and had three dialysis sessions using standard of care needles (control) over one week. Sessions were sequential. Dialysis session flow rates for 11 of these patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min. The same 15 subjects then had six dialysis sessions over the next two weeks using the Hemotek V Needle (test article, experimental) at the same assigned flow rates. Sessions were sequential.
Standard of Care (Control) 3x - One Week STARTED	15
Standard of Care (Control) 3x - One Week 400 mL/Min Flow Rate	11
Standard of Care (Control) 3x - One Week 450 mL/Min Flow Rate	4
Standard of Care (Control) 3x - One Week COMPLETED	15
Standard of Care (Control) 3x - One Week NOT COMPLETED	0
V Needle (Experimental) 6x - Two Weeks STARTED	15
V Needle (Experimental) 6x - Two Weeks 400 mL/Min Flow Rate	11
V Needle (Experimental) 6x - Two Weeks 450 mL/Min Flow Rate	4
V Needle (Experimental) 6x - Two Weeks COMPLETED	15
V Needle (Experimental) 6x - Two Weeks NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Standard of Care vs. V Needle Performance Assessment n=15 Participants 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.
Age, Continuous	52.7 years STANDARD_DEVIATION 10.22 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Standard of Care (Baseline/Control) Performance Assessment n=45 Sessions Subjects will undergo three dialysis sessions using standard of care needles (control). Sessions are sequential and unless otherwise noted takes one week to complete three sessions. Flow rate for 11 of these patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.	V Needle (Test) Performance Assessment n=90 Sessions Subjects will undergo six dialysis sessions using the Hemotek V Needle (test article). Sessions are sequential and unless otherwise noted takes two weeks to complete six sessions. Flow rate for these 11 patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.
Percentage of Successful Hemodialysis Sessions	100 percentage of successful sessions	98.9 percentage of successful sessions

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Standard of Care (Baseline/Control) Performance Assessment n=45 Sessions Subjects will undergo three dialysis sessions using standard of care needles (control). Sessions are sequential and unless otherwise noted takes one week to complete three sessions. Flow rate for 11 of these patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.	V Needle (Test) Performance Assessment n=90 Sessions Subjects will undergo six dialysis sessions using the Hemotek V Needle (test article). Sessions are sequential and unless otherwise noted takes two weeks to complete six sessions. Flow rate for these 11 patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.
Machine Alarm Rate (Blood Alarms Only) During Hemodialysis Therapy Sessions, Including False Alarms.	1.11 alarms/session Standard Deviation 0.25	1.92 alarms/session Standard Deviation 0.51

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Standard of Care (Baseline/Control) Performance Assessment n=6 Venous Alarms Subjects will undergo three dialysis sessions using standard of care needles (control). Sessions are sequential and unless otherwise noted takes one week to complete three sessions. Flow rate for 11 of these patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.	V Needle (Test) Performance Assessment n=32 Venous Alarms Subjects will undergo six dialysis sessions using the Hemotek V Needle (test article). Sessions are sequential and unless otherwise noted takes two weeks to complete six sessions. Flow rate for these 11 patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.
False Alarms Per Session (as a % of All Venous Alarms Per Same Session)	82 percentage of false alarms	83.66 percentage of false alarms

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Standard of Care (Baseline/Control) Performance Assessment n=45 Alarms Subjects will undergo three dialysis sessions using standard of care needles (control). Sessions are sequential and unless otherwise noted takes one week to complete three sessions. Flow rate for 11 of these patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.	V Needle (Test) Performance Assessment n=90 Alarms Subjects will undergo six dialysis sessions using the Hemotek V Needle (test article). Sessions are sequential and unless otherwise noted takes two weeks to complete six sessions. Flow rate for these 11 patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.
Venous Alarm Rate (All) Per Session	0.14 venous alarms/session Standard Deviation 0.43	0.36 venous alarms/session Standard Deviation 0.38

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

% All (false) Alarms Related to V Needle footplate opening inappropriately during each hemodialysis session

Outcome measures

Measure	Standard of Care (Baseline/Control) Performance Assessment Subjects will undergo three dialysis sessions using standard of care needles (control). Sessions are sequential and unless otherwise noted takes one week to complete three sessions. Flow rate for 11 of these patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.	V Needle (Test) Performance Assessment n=13 Alarms Subjects will undergo six dialysis sessions using the Hemotek V Needle (test article). Sessions are sequential and unless otherwise noted takes two weeks to complete six sessions. Flow rate for these 11 patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.
% All (False) Alarms Related to V Needle Footplate Opening Inappropriately	—	0 % All (false) Alarms Related to V Needle

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Standard of Care (Baseline/Control) Performance Assessment n=50 Alarms Subjects will undergo three dialysis sessions using standard of care needles (control). Sessions are sequential and unless otherwise noted takes one week to complete three sessions. Flow rate for 11 of these patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.	V Needle (Test) Performance Assessment n=173 Alarms Subjects will undergo six dialysis sessions using the Hemotek V Needle (test article). Sessions are sequential and unless otherwise noted takes two weeks to complete six sessions. Flow rate for these 11 patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.
% All Alarms Related to Venous Needle	12 % of all alarms related to venous needle	18 % of all alarms related to venous needle

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Standard of Care (Baseline/Control) Performance Assessment n=45 Sessions Subjects will undergo three dialysis sessions using standard of care needles (control). Sessions are sequential and unless otherwise noted takes one week to complete three sessions. Flow rate for 11 of these patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.	V Needle (Test) Performance Assessment n=90 Sessions Subjects will undergo six dialysis sessions using the Hemotek V Needle (test article). Sessions are sequential and unless otherwise noted takes two weeks to complete six sessions. Flow rate for these 11 patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.
% Hemodialysis Sessions Requiring a Change to Blood Flow Rate Setting During Therapy	6.67 percentage of hemodialysis sessions	3.33 percentage of hemodialysis sessions

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Standard of Care (Baseline/Control) Performance Assessment n=33 Sessions Subjects will undergo three dialysis sessions using standard of care needles (control). Sessions are sequential and unless otherwise noted takes one week to complete three sessions. Flow rate for 11 of these patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.	V Needle (Test) Performance Assessment n=66 Sessions Subjects will undergo six dialysis sessions using the Hemotek V Needle (test article). Sessions are sequential and unless otherwise noted takes two weeks to complete six sessions. Flow rate for these 11 patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.
Mean Venous Pressure (in mm Hg) Per Hemodialyis Session for Subjects Dialyzing at 400 mL/Min	179 mm Hg/session Standard Deviation 31	208 mm Hg/session Standard Deviation 37

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Standard of Care (Baseline/Control) Performance Assessment n=12 Sessions Subjects will undergo three dialysis sessions using standard of care needles (control). Sessions are sequential and unless otherwise noted takes one week to complete three sessions. Flow rate for 11 of these patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.	V Needle (Test) Performance Assessment n=24 Sessions Subjects will undergo six dialysis sessions using the Hemotek V Needle (test article). Sessions are sequential and unless otherwise noted takes two weeks to complete six sessions. Flow rate for these 11 patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.
Mean Venous Pressure (in mm Hg) Per Hemodialyis Session for Subjects Dialyzing at 450 mL/Min	213 mm Hg/session Standard Deviation 30	247 mm Hg/session Standard Deviation 35

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Standard of Care (Baseline/Control) Performance Assessment n=33 Sessions Subjects will undergo three dialysis sessions using standard of care needles (control). Sessions are sequential and unless otherwise noted takes one week to complete three sessions. Flow rate for 11 of these patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.	V Needle (Test) Performance Assessment n=66 Sessions Subjects will undergo six dialysis sessions using the Hemotek V Needle (test article). Sessions are sequential and unless otherwise noted takes two weeks to complete six sessions. Flow rate for these 11 patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.
Mean Transmembrane Pressure (in mm Hg) Per Session for Subjects Dialyzing at 400 mL/Min	48 mm Hg/session Standard Deviation 17	48 mm Hg/session Standard Deviation 16

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Standard of Care (Baseline/Control) Performance Assessment n=12 Sessions Subjects will undergo three dialysis sessions using standard of care needles (control). Sessions are sequential and unless otherwise noted takes one week to complete three sessions. Flow rate for 11 of these patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.	V Needle (Test) Performance Assessment n=24 Sessions Subjects will undergo six dialysis sessions using the Hemotek V Needle (test article). Sessions are sequential and unless otherwise noted takes two weeks to complete six sessions. Flow rate for these 11 patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.
Mean Transmembrane Pressure (mm Hg) Per Session for Subjects Dialyzing at 450 mL/Min	43 mm Hg/session Standard Deviation 14	44 mm Hg/session Standard Deviation 13

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Standard of Care (Baseline/Control) Performance Assessment n=33 Sessions Subjects will undergo three dialysis sessions using standard of care needles (control). Sessions are sequential and unless otherwise noted takes one week to complete three sessions. Flow rate for 11 of these patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.	V Needle (Test) Performance Assessment n=66 Sessions Subjects will undergo six dialysis sessions using the Hemotek V Needle (test article). Sessions are sequential and unless otherwise noted takes two weeks to complete six sessions. Flow rate for these 11 patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.
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	-175 mm Hg/session Standard Deviation 36

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Standard of Care (Baseline/Control) Performance Assessment n=12 Sessions Subjects will undergo three dialysis sessions using standard of care needles (control). Sessions are sequential and unless otherwise noted takes one week to complete three sessions. Flow rate for 11 of these patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.	V Needle (Test) Performance Assessment n=24 Sessions Subjects will undergo six dialysis sessions using the Hemotek V Needle (test article). Sessions are sequential and unless otherwise noted takes two weeks to complete six sessions. Flow rate for these 11 patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.
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	-199 mm Hg/session Standard Deviation 29

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

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.

Outcome measures

Measure	Standard of Care (Baseline/Control) Performance Assessment n=45 Sessions Subjects will undergo three dialysis sessions using standard of care needles (control). Sessions are sequential and unless otherwise noted takes one week to complete three sessions. Flow rate for 11 of these patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.	V Needle (Test) Performance Assessment n=90 Sessions Subjects will undergo six dialysis sessions using the Hemotek V Needle (test article). Sessions are sequential and unless otherwise noted takes two weeks to complete six sessions. Flow rate for these 11 patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.
% Hemodialysis Sessions Where 'Achieved' Blood Flow Rate is Within 75% of 'Prescribed' Blood Flow Rate	95.6 percentage of sessions	98.9 percentage of sessions

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

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.

Outcome measures

Measure	Standard of Care (Baseline/Control) Performance Assessment n=45 Sessions Subjects will undergo three dialysis sessions using standard of care needles (control). Sessions are sequential and unless otherwise noted takes one week to complete three sessions. Flow rate for 11 of these patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.	V Needle (Test) Performance Assessment n=90 Sessions Subjects will undergo six dialysis sessions using the Hemotek V Needle (test article). Sessions are sequential and unless otherwise noted takes two weeks to complete six sessions. Flow rate for these 11 patients was 400 mL/min and flow rate for 4 of these patients was 450 mL/min.
% Sessions Where Clinician Was Able to Successfully Cannulate Fistula	100 percentage of hemodialysis sessions	98.9 percentage of hemodialysis sessions

Adverse Events

Control Device

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Test Device

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control Device n=15 participants at risk All subjects using SysLoc Mini, the Standard of Care (control).	Test Device n=15 participants at risk All subjects using V Needle, the test device (experimental). These subjects are the same as the control arm.
General disorders High Blood Pressure	0.00% 0/15 • All AE data and outcomes data was captured per session, with 3 control sessions, in the first week, followed by 6 experimental sessions over the next two weeks, resulting in a three week data collection period per subject. Additionally, all subjects were followed for 7 more days following each of their study dialysis sessions to observe for any potential AEs. Thus, data collection coupled with AE observation resulted in an overall observation period of 4 weeks total per subject. Patients were monitored during and after therapy for the appearance of any AE's or potential symptoms of AE's. Patient medical records were tracked between each session. Follow-up contact was made 7 days following the last study session to determine if any AE's or potential symptoms of AE's had occurred. Patients had clinical study coordinator contact information to self-report any other potential AE's or potential symptoms of AE's.	6.7% 1/15 • Number of events 1 • All AE data and outcomes data was captured per session, with 3 control sessions, in the first week, followed by 6 experimental sessions over the next two weeks, resulting in a three week data collection period per subject. Additionally, all subjects were followed for 7 more days following each of their study dialysis sessions to observe for any potential AEs. Thus, data collection coupled with AE observation resulted in an overall observation period of 4 weeks total per subject. Patients were monitored during and after therapy for the appearance of any AE's or potential symptoms of AE's. Patient medical records were tracked between each session. Follow-up contact was made 7 days following the last study session to determine if any AE's or potential symptoms of AE's had occurred. Patients had clinical study coordinator contact information to self-report any other potential AE's or potential symptoms of AE's.
Respiratory, thoracic and mediastinal disorders Lung Edema	0.00% 0/15 • All AE data and outcomes data was captured per session, with 3 control sessions, in the first week, followed by 6 experimental sessions over the next two weeks, resulting in a three week data collection period per subject. Additionally, all subjects were followed for 7 more days following each of their study dialysis sessions to observe for any potential AEs. Thus, data collection coupled with AE observation resulted in an overall observation period of 4 weeks total per subject. Patients were monitored during and after therapy for the appearance of any AE's or potential symptoms of AE's. Patient medical records were tracked between each session. Follow-up contact was made 7 days following the last study session to determine if any AE's or potential symptoms of AE's had occurred. Patients had clinical study coordinator contact information to self-report any other potential AE's or potential symptoms of AE's.	6.7% 1/15 • Number of events 1 • All AE data and outcomes data was captured per session, with 3 control sessions, in the first week, followed by 6 experimental sessions over the next two weeks, resulting in a three week data collection period per subject. Additionally, all subjects were followed for 7 more days following each of their study dialysis sessions to observe for any potential AEs. Thus, data collection coupled with AE observation resulted in an overall observation period of 4 weeks total per subject. Patients were monitored during and after therapy for the appearance of any AE's or potential symptoms of AE's. Patient medical records were tracked between each session. Follow-up contact was made 7 days following the last study session to determine if any AE's or potential symptoms of AE's had occurred. Patients had clinical study coordinator contact information to self-report any other potential AE's or potential symptoms of AE's.

Other adverse events

Measure	Control Device n=15 participants at risk All subjects using SysLoc Mini, the Standard of Care (control).	Test Device n=15 participants at risk All subjects using V Needle, the test device (experimental). These subjects are the same as the control arm.
Vascular disorders SYNCOPE	6.7% 1/15 • Number of events 1 • All AE data and outcomes data was captured per session, with 3 control sessions, in the first week, followed by 6 experimental sessions over the next two weeks, resulting in a three week data collection period per subject. Additionally, all subjects were followed for 7 more days following each of their study dialysis sessions to observe for any potential AEs. Thus, data collection coupled with AE observation resulted in an overall observation period of 4 weeks total per subject. Patients were monitored during and after therapy for the appearance of any AE's or potential symptoms of AE's. Patient medical records were tracked between each session. Follow-up contact was made 7 days following the last study session to determine if any AE's or potential symptoms of AE's had occurred. Patients had clinical study coordinator contact information to self-report any other potential AE's or potential symptoms of AE's.	0.00% 0/15 • All AE data and outcomes data was captured per session, with 3 control sessions, in the first week, followed by 6 experimental sessions over the next two weeks, resulting in a three week data collection period per subject. Additionally, all subjects were followed for 7 more days following each of their study dialysis sessions to observe for any potential AEs. Thus, data collection coupled with AE observation resulted in an overall observation period of 4 weeks total per subject. Patients were monitored during and after therapy for the appearance of any AE's or potential symptoms of AE's. Patient medical records were tracked between each session. Follow-up contact was made 7 days following the last study session to determine if any AE's or potential symptoms of AE's had occurred. Patients had clinical study coordinator contact information to self-report any other potential AE's or potential symptoms of AE's.
Vascular disorders CLOT	0.00% 0/15 • All AE data and outcomes data was captured per session, with 3 control sessions, in the first week, followed by 6 experimental sessions over the next two weeks, resulting in a three week data collection period per subject. Additionally, all subjects were followed for 7 more days following each of their study dialysis sessions to observe for any potential AEs. Thus, data collection coupled with AE observation resulted in an overall observation period of 4 weeks total per subject. Patients were monitored during and after therapy for the appearance of any AE's or potential symptoms of AE's. Patient medical records were tracked between each session. Follow-up contact was made 7 days following the last study session to determine if any AE's or potential symptoms of AE's had occurred. Patients had clinical study coordinator contact information to self-report any other potential AE's or potential symptoms of AE's.	13.3% 2/15 • Number of events 3 • All AE data and outcomes data was captured per session, with 3 control sessions, in the first week, followed by 6 experimental sessions over the next two weeks, resulting in a three week data collection period per subject. Additionally, all subjects were followed for 7 more days following each of their study dialysis sessions to observe for any potential AEs. Thus, data collection coupled with AE observation resulted in an overall observation period of 4 weeks total per subject. Patients were monitored during and after therapy for the appearance of any AE's or potential symptoms of AE's. Patient medical records were tracked between each session. Follow-up contact was made 7 days following the last study session to determine if any AE's or potential symptoms of AE's had occurred. Patients had clinical study coordinator contact information to self-report any other potential AE's or potential symptoms of AE's.

Additional Information

Chief Scientific Officer

Hemotek Medical Inc

Phone: 7074942895

Email: patrick@hemotekmedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place