Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-24 @ 1:28 PM
NCT ID:
NCT05217095
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05217095
Study Brief:
Protocol Section:
NCT05217095