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

February 28, 2022 updated by: D.med Consulting GmbH
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • North Macedonia
      • Skopje, North Macedonia, 1000
        • Special Hospital for Nephrology and Dialysis Diamed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Interventional Group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Alarms
Time Frame: 1 study day
Incidence of alarms leading to end of treatment, cause identification
1 study day
Product defects
Time Frame: 1 study day
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
Time Frame: 1 study day
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
Time Frame: 1 study day
Incidence of "recoverable" alarms, cause of alarms i.e.arterial/venous pressure outside of set range/limits
1 study day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Completion Rate
Time Frame: 1 study day
The completion rate of a dialysis session according to prescription. The study is considered to be successful, if at least 8 patients reach the effective dialysis time.
1 study day
Average Blood Flow Rate
Time Frame: 1 study day
The average blood flow rate is measured during the dialysis treatment. Maintenance of preset blood flow rates throughout the dialysis in at least 8 out of 10 patients
1 study day
Arterial pressure
Time Frame: 1 study day
The arterial pressure is measured in mmHg.
1 study day
Venous pressure
Time Frame: 1 study day
The venous pressure is measured in mmHg.
1 study day
Impeller RPM
Time Frame: 1 study day
The rotation of the impeller pump is measured in rpm.
1 study day
Dialysis Dose as single pool Kt/V
Time Frame: 1 study day
The delivered dialysis dose as single-pool Kt/V. Achievement of a spKt/V > 1.4 in at least 8 out of 10 patients.
1 study day
Dialysis Dose as Urea Reduction Ratio (URR)
Time Frame: 1 study day
The delivered dialysis dose as URR.
1 study day
Ultrafiltration Volume
Time Frame: 1 study day
Total ultrafiltration volume (ml). Achievement of preset total ultrafiltration volume (ml) to reach dry weight target in at least 8 out of 10 patients.
1 study day
Body weight change
Time Frame: 1 study day
Patient body weight change (before treatment vs. after treatment).
1 study day
pH
Time Frame: 1 study day
The blood level of pH is measured pre/post HD. Achievement of results in laboratory acceptable ranges,
1 study day
Bicarbonate
Time Frame: 1 study day
The blood level of Bicarbonate is measured pre/post HD. Achievement of results in laboratory acceptable ranges.
1 study day
Potassium
Time Frame: 1 study day
The blood level of Potassium is measured pre/post HD. Achievement of results in laboratory acceptable ranges,
1 study day
Sodium
Time Frame: 1 study day
The blood level of Sodium is measured pre/post HD. Achievement of results in laboratory acceptable ranges.
1 study day
Chloride
Time Frame: 1 study day
The blood level of Chloride is measured pre/post HD. Achievement of results in laboratory acceptable ranges.
1 study day
Free hemoglobin
Time Frame: 1 study day
The blood level of free hemoglobin (fHb measured on 30 min) to be in acceptable ranges for hemolysis
1 study day
Anticoagulation
Time Frame: 1 study day
The total dose of anticoagulation consumption not to exceed patient treatment dose as I.U per kg
1 study day
Clotting Score
Time Frame: 1 study day

The clotting score of dialyzer(visual check, using common scale for dialyzer study)

  1. No visible thrombosed fibers
  2. A few visible thrombosed fibers
  3. Moderately visible thrombosed fibers
  4. Many visible thrombosed fibers
  5. Completely visible thrombosed fibers

So the score goes from 1 (good) to 5 (bad).
1 study day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
D.med Consulting GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fresenius Medical Care Deutschland GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elena Babalj-Banskolieva, Dr., Specialized Hospital for Nephrology and Dialysis Diamed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D.Med 20-01 Convergence

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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