Clinical Trial on a Novel Blood Pumping System in 4008A Hemodialysis Machine

NCT05217095 | Completed

• 1 other identifier: D.Med 20-01 Convergence
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial will be to verify the feasibility of using an impeller system instead of a roller pump for hemodialysis, using the established 4008 hemodialysis system and a Convergence Dialyzer with design changes made to the FX-Coral P 600 dialyzer.

Conditions

Renal Dialysis

Outcome Measures

Primary Outcomes (4)

• Incidence of Alarms

  Incidence of alarms leading to end of treatment, cause identification

  1 study day

• Product defects

  Product defects leading to end of treatment, cause identification

  1 study day

• Serious adverse event / adverse event/ Serious adverse device effect/ Adverse device effect/Unanticipated serious adverse device effect

  Incidence of Serious adverse event / adverse event/ Serious adverse device effect/ Adverse device effect/Unanticipated serious adverse device effect

  1 study day

• Incidence of "recoverable" alarms

  Incidence of "recoverable" alarms, cause of alarms i.e.arterial/venous pressure outside of set range/limits

  1 study day

Secondary Outcomes (17)

• Completion Rate

  1 study day

• Average Blood Flow Rate

  1 study day

• Arterial pressure

  1 study day

• Venous pressure

  1 study day

• Impeller RPM

  1 study day

Study Arms (1)

Interventional Group

OTHER

Each patient will be treated for one session of dialysis after enrolled. Each of them will have only one treatment in the middle of the week (Wednesday or Thursday). The patients will be treated using 4008A dialysis machines in combination with a sidecar and the convergence dialyzer as investigational devices.Each patient will be treated according their regular treatment and laboratory analysis will be taken. The blood level of free hemoglobin ( fHb ) will be taken on 30 min by use of HemoCue device. ACT time will be measured on 15 min and for that 0.5 ml blood from venous line will be taken.

Device: Convergence Dialyzer

Interventions

Convergence Dialyzer DEVICE

The Convergence dialyzer with design changes made to FX Coral 600 dialyzer will be tested together with Sidecar. In the dialyzer is integrated centrifugal-flow blood pump.The centrifugal-flow blood pump replaces the peristaltic roller pump of the extracorporeal circuit which pumps blood from patient to the dialyzer and from dialyzer to the patient. The centrifugal-flow blood pump is designed to transport blood from the patient to the dialyzer, and after purification, return the blood to patient.

Interventional Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be up to 18-85 years
• Hemodialysis Schedule: 3 times per week; app. 3- 5 hour treatment
• Stable clinical conditions: no recent (last 2 weeks) hospitalization events, no recent main surgery (last 3 weeks), no acute cardiological problems, hemoglobine levels in the DOQI Guideline ranges.
• Hemodynamic stability during dialysis i.c. number of sessions complicated by acute hypotension events or arrhythmia \<25% in the last 3 Months
• Well-functioning AVF vascular access: access recirculation ≤10%
• No coagulation disorders and anticoagulant therapy
• Patients must be using a similar size dialyzer as Convergence dialyzer
• Signed Inform consent form.

You may not qualify if:

• Unstable clinical condition: recent hospitalization, recent surgery, anemia, active neoplastic diseases,shock or unstable cardiac function and intolerable to extracorporeal treatment
• Hemodynamic instability during the dialysis sessions; more than 25% of the sessions complicated by acute hypotension or arrhythmic events.Presence of clinically significant abnormality on a 12-lead ECG at Screening that, at the investigator's clinical judgment, may compromise the safety of the patient or affect the outcome of the study.
• History or presence of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status within 6 months prior to the study Convergence system treatment.
• Abnormal liver function values including but not limited to the aspartate transaminase, alanine transaminase or alkaline phosphatase ≥5 × upper limit normal.
• Any uncontrolled clinically significant respiratory disease in the investigator's opinion (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis, asthma).
• Temporary excluded will be patients with increased body temperature due to some infective disease, dehydration, diarrhea, hyperglycemia,
• Severe bleeding, or history or evidence of bleeding diathesis or coagulopathy with the risk of bleeding or have to put on dialysis without anticoagulant.
• Using temporary or permanent dialysis catheter
• Uncontrolled diabetes mellitus or hypertension, at the discretion of investigator.
• Known pregnancy and lactating without pregnancy test
• Patient has known allergy or hypersensitivity reaction to dialyzer membrane or other disposable
• Any conditions significantly affecting the nervous system (i.e., neuropathic conditions or nervous system damage
• Patient shows evidence of a condition (psychological, emotional problems, any disorders or resultant therapy) that is likely to invalidate health information, consent, or limit the ability of the patient to comply with the protocol requirements in the opinion of the investigator
• Any other conditions at the discretion of investigator not suitable for patients to participate in the study

Sponsors & Collaborators

• D.med Consulting GmbH: lead
• Fresenius Medical Care Deutschland GmbH: collaborator

Study Sites (1)

Special Hospital for Nephrology and Dialysis Diamed

Skopje, 1000, North Macedonia

Location

Study Officials

• Elena Babalj-Banskolieva, Dr.

  Specialized Hospital for Nephrology and Dialysis Diamed

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: February 1, 2022
• Study Start: January 19, 2022
• Primary Completion: January 22, 2022
• Study Completion: February 22, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)