NCT05493423: Clinic-SAVER

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

Completed NA Results posted Last updated 5 February 2025

What this trial tests

NA trial testing V Needle AV Fistula Set in End Stage Renal Disease in 15 participants. Completed in 17 July 2023.

Timeline

7 November 2022

Primary endpoint
10 July 2023

17 July 2023

Quick facts

Lead sponsor	Hemotek Medical Inc
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	15
Start date	7 November 2022
Primary completion	10 July 2023
Estimated completion	17 July 2023
Sites	1 location across United States

Drugs / interventions tested

• V Needle AV Fistula Set

Conditions studied

• End Stage Renal Disease — all drugs for End Stage Renal Disease →

Sponsor

Hemotek Medical Inc

Who can join

22 and older, any sex, with End Stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Successful Hemodialysis Sessions Primary · 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.

Group	Value	95% CI
Control Device	100
Test Device	98.9

Machine Alarm Rate (Blood Alarms Only) During Hemodialysis Therapy Sessions, Including False Alarms. Secondary · 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.

Group	Value	95% CI
Control Device	1.11	± 0.25
Test Device	1.92	± 0.51

False Alarms Per Session (as a % of All Venous Alarms Per Same Session) Secondary · 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.

Group	Value	95% CI
Standard of Care (Baseline/Control) Performance Assessment	82
V Needle (Test) Performance Assessment	83.66

Venous Alarm Rate (All) Per Session Secondary · 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

Group	Value	95% CI
Standard of Care (Baseline/Control) Performance Assessment	0.14	± 0.43
V Needle (Test) Performance Assessment	0.36	± 0.38

% All (False) Alarms Related to V Needle Footplate Opening Inappropriately Secondary · 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

Group	Value	95% CI
V Needle (Test) Performance Assessment	0

% All Alarms Related to Venous Needle Secondary · 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

Group	Value	95% CI
Standard of Care (Baseline/Control) Performance Assessment	12
V Needle (Test) Performance Assessment	18

% Hemodialysis Sessions Requiring a Change to Blood Flow Rate Setting During Therapy Secondary · 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

Group	Value	95% CI
Standard of Care (Baseline/Control) Performance Assessment	6.67
V Needle (Test) Performance Assessment	3.33

Mean Venous Pressure (in mm Hg) Per Hemodialyis Session for Subjects Dialyzing at 400 mL/Min Secondary · 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

Group	Value	95% CI
Standard of Care (Baseline/Control) Performance Assessment	179	± 31
V Needle (Test) Performance Assessment	208	± 37

Mean Venous Pressure (in mm Hg) Per Hemodialyis Session for Subjects Dialyzing at 450 mL/Min Secondary · 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

Group	Value	95% CI
Standard of Care (Baseline/Control) Performance Assessment	213	± 30
V Needle (Test) Performance Assessment	247	± 35

Mean Transmembrane Pressure (in mm Hg) Per Session for Subjects Dialyzing at 400 mL/Min Secondary · 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

Group	Value	95% CI
Standard of Care (Baseline/Control) Performance Assessment	48	± 17
V Needle (Test) Performance Assessment	48	± 16

Mean Transmembrane Pressure (mm Hg) Per Session for Subjects Dialyzing at 450 mL/Min Secondary · 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

Group	Value	95% CI
Standard of Care (Baseline/Control) Performance Assessment	43	± 14
V Needle (Test) Performance Assessment	44	± 13

Mean Arterial Pressure (in mm Hg) Per Session for Subjects Dialyzing at a Flow Rate 400 mL/Min Secondary · 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

Group	Value	95% CI
Standard of Care (Baseline/Control) Performance Assessment	-167	± 32
V Needle (Test) Performance Assessment	-175	± 36

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control Device

Serious: 0/15 (0%)

Deaths: 0/15

Test Device

Serious: 1/15 (7%)

Deaths: 0/15

Serious adverse events (2 terms)

Reaction	System	Control Device	Test Device
High Blood Pressure	General disorders	—	—
Lung Edema	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Control Device	Test Device
CLOT	Vascular disorders	—	—
SYNCOPE	Vascular disorders	—	—

Most-reported serious reactions: High Blood Pressure, Lung Edema.

Data from ClinicalTrials.gov NCT05493423 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.