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

NCT05493423 | Completed Results DMC FDA Device

• 2 other identifiers: CIP 0015R44DK101253
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

hemodialysis; dialysis; dislodgement; venous needle; venous needle dislodgement; AV fistula set

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (14)

• 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

• 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)

• 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

Study Arms (1)

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).

Device: V Needle AV Fistula Set

Interventions

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.

Also known as: V Needle

Standard of Care vs. V Needle Performance Assessment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Hemotek Medical Inc: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Davita

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Needles

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: Hemotek Medical Inc

patrick@hemotekmedical.com

7074942895

Study Officials

• Wesley Calhoun, MD

  Davita Clinical Research

  PRINCIPAL INVESTIGATOR

• Tahira Alves, MD

  Davita Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 9, 2022
• Study Start: November 7, 2022
• Primary Completion: July 10, 2023
• Study Completion: July 17, 2023
• Last Updated: February 5, 2025
• Results First Posted: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)