End Stage Renal DiseaseClinic-SAVERNCT05493423
Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis
A study testing V Needle AV Fistula Set in people with End Stage Renal Disease, run by Hemotek Medical Inc at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- V Needle AV Fistula Set
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2022to 17 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with end-stage renal disease receiving chronic hemodialysis in a clinical setting.
- Subjects must be able to receive hemodialysis with the Hemotek 15-gauge, 1 inch length V Needle, with 12 inch tubing.
- Age greater than or equal to 22 years old at screening.
- Vascular access via a mature arteriovenous (AV) fistula or graft in the arm and determined to be adequate for a chronic hemodialysis therapy.
- AV fistula has already been demonstrated to adequately permit one or more hemodialysis sessions.
- Subject prescribed blood flow rates between 200 ml/min and 450 ml/min
Show all 11Show fewer
- In women with child-bearing potential, negative urine or serum pregnancy test at Screening.
- Subject able to communicate effectively with investigative staff, competent and willing to give written informed consent, and able to comply with entire study procedures.
- Hemoglobin ≥9 g/dL (consistent with KDOQI guidelines)
- Normal platelet count (≥150,000 /mm3)
- International Normalized Ratio (INR) ≤ 1.5
Who cannot join
- Subjects receiving chronic hemodialysis with a vascular catheter.
- Subjects with vascular access that is determined by the clinician to be unacceptable for a hemodialysis procedure.
- Patients with a bleeding diathesis
- Patients receiving anti-coagulants
- Previous vascular access surgery (≤30 days from study entry) or planned access surgery
- Known hypersensitivity to any imaging agents (e.g., contrast) that may be required during the study period
Show all 11Show fewer
- Patients with confirmed vasculitis
- Vascular access infection or systemic active infection within 30 days of study entry
- Life expectancy less than 12 months
- Planned renal transplantation or planned conversion to peritoneal dialysis
- Subjects with any condition determined by the investigator that precludes them from safely participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- End Stage Renal Disease
- Being tested
- V Needle AV Fistula Set
- Keywords
- hemodialysis, dialysis, dislodgement, venous needle, venous needle dislodgement, AV fistula set
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V Needle AV Fistula SetDevice
Also called V Needle
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: V Needle AV Fistula Set |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start7 Nov 2022
- Primary completion10 Jul 2023
- Study completion17 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hemotek Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wesley Calhoun, MD, Principal investigator, Davita Clinical ResearchTahira Alves, MD, Principal investigator, Davita Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493423
- Sponsor's protocol ID
- CIP 001
- Other IDs
- 5R44DK101253
- Acronym
- Clinic-SAVER
- Status last verified
- Jan 2025
- First submitted
- 3 Aug 2022
- Last updated
- 5 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis: Clinic-SAVER
- ClinicalTrials.gov ID
- NCT05493423
- Acronym / sponsor ID
- Clinic-SAVER / CIP 001
- Conditions
- End Stage Renal Disease
- Keywords
- hemodialysis, dialysis, dislodgement, venous needle, venous needle dislodgement, AV fistula set
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hemotek Medical IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 17 Jul 2023 (actual)
- First posted
- 9 Aug 2022 (actual)
- Results
- Posted 5 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of Care vs. V Needle Performance Assessment | Experimental | Device: V Needle AV Fistula SetSubjects 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). |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects with end-stage renal disease receiving chronic hemodialysis in a clinical setting.
- Subjects must be able to receive hemodialysis with the Hemotek 15-gauge, 1 inch length V Needle, with 12 inch tubing.
- Age greater than or equal to 22 years old at screening.
- Vascular access via a mature arteriovenous (AV) fistula or graft in the arm and determined to be adequate for a chronic hemodialysis therapy.
- AV fistula has already been demonstrated to adequately permit one or more hemodialysis sessions.
Key exclusion criteria (11 listed)
- Subjects receiving chronic hemodialysis with a vascular catheter.
- Subjects with vascular access that is determined by the clinician to be unacceptable for a hemodialysis procedure.
- Patients with a bleeding diathesis
- Patients receiving anti-coagulants
- Previous vascular access surgery (≤30 days from study entry) or planned access surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V Needle AV Fistula SetAlso: V NeedleHemotek 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. | Device | Standard of Care vs. V Needle Performance Assessment |
Primary outcome
Percentage of Successful Hemodialysis Sessions
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for End Stage Renal Disease
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Active, not recruitingObservational study
Acetoacetate and Acetate Metabolism in Patients With Chronic Kidney Failure.(RENO-TEP)
Kidney Failure, Chronic
Active, not recruitingObservational study
Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients
End Stage Renal Disease
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wesley Calhoun, MD principal investigator
Davita Clinical Research
Tahira Alves, MD principal investigator
Davita Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V Needle AV Fistula Set in people with End Stage Renal Disease, run by Hemotek Medical Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Successful Hemodialysis Sessions (time frame: 3 weeks total: 1 week for 3 control sessions and 2 weeks for 6 experimental (V Needle) sessions per subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.