Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R44DK101253 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care vs. V Needle Performance Assessment | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V Needle AV Fistula Set | Device | 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. |
| 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 |
Not provided
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wesley Calhoun, MD | Davita Clinical Research | Principal Investigator |
| Tahira Alves, MD | Davita Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Davita | San Antonio | Texas | 78229 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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..
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Standard of Care (Control) 3x - One Week |
| |||||||||||||||||||
| V Needle (Experimental) 6x - Two Weeks |
|
All 15 subjects served as their own controls.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Study subjects who meet eligibility criteria at each site | Posted | Number | percentage of successful sessions | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | Sessions | Sessions |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Device | All subjects using SysLoc Mini, the Standard of Care (control). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High Blood Pressure | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SYNCOPE | Vascular disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Scientific Officer | Hemotek Medical Inc | 7074942895 | patrick@hemotekmedical.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2023 | Jan 9, 2025 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009339 | Needles |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Information determined during enrollment interview | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
All subjects using V Needle |
|
|
|
| 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. | The same 15 subjects served as their own controls. | Posted | Mean | Standard Deviation | alarms/session | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | Sessions | Sessions |
|
|
|
|
| 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. | Posted | Number | percentage of false alarms | 3 weeks (time required to complete all control and test dialysis sessions per patient) | Venous Alarms | Venous Alarms |
|
|
|
|
| Other Pre-specified | Venous Alarm Rate (All) Per Session | Rate of venous alarms per hemodialysis session | Posted | Mean | Standard Deviation | venous alarms/session | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | Alarms | Alarms |
|
|
|
|
| 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 | There are 0 units analyzed in the control arm because the control device does not have a protective footplate to assess. | Posted | Number | % All (false) Alarms Related to V Needle | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | Alarms | Alarms |
|
|
|
|
| Other Pre-specified | % All Alarms Related to Venous Needle | % of all alarms related to Venous needle per hemodialysis session | Posted | Number | % of 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 | Alarms | Alarms |
|
|
|
|
| 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 | Posted | Number | percentage of hemodialysis sessions | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | Sessions | Sessions |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | mm Hg/session | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | Sessions | Sessions |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | mm Hg/session | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | Sessions | Sessions |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | mm Hg/session | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | Sessions | Sessions |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | mm Hg/session | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | Sessions | Sessions |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | mm Hg/session | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | Sessions | Sessions |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | mm Hg/session | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | Sessions | Sessions |
|
|
|
|
| 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. | Study subjects who meet eligibility criteria at each site | Posted | Number | percentage of sessions | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | Sessions | Sessions |
|
|
|
|
| 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. | Study subjects who meet eligibility criteria at each site | Posted | Number | percentage of hemodialysis sessions | 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject | Sessions | Sessions |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | Test Device | All subjects using V Needle, the test device (experimental). These subjects are the same as the control arm. | 0 | 15 | 1 | 15 | 2 | 15 |
| Lung Edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| CLOT | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |