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:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT07017933
Eligibility Criteria:
Inclusion Criteria:
To be eligible for participation in this study, an individual must meet all the following criteria:
1. A candidate for elective or urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery
2. Male or Female age 22 to 85 years
3. Estimated glomerular filtration rate (eGFR) 15 - 60 mL/min/1.73m2
4. Signed and dated informed consent
5. Female patients of childbearing potential must:
1. have negative pregnancy test at the informed consent visit,
2. be using previously initiated approved and effective contraception from the informed consent visit through completion of the study \*The only recommended contraception is condoms.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
1. Any individual, or their legally authorized representative (LAR), who does not understand the requests and risks of participating in the clinical trial or is unable to give informed consent
2. Pregnancy or lactation
3. Prior cardiac surgery within the last 6 months
4. Hemodynamic instability as determined by the Principal Investigator
5. Immunosuppression
6. Active infections (e.g. HIV, Tbc, and all types of Hepatitis)
7. History of polycystic kidney disease
8. Patients with only one active kidney or one poorly functioning kidney
9. Evidence of current kidney obstruction (e.g., Kidney stones)
10. Evidence of current hydronephrosis
11. Active upper and/or lower urinary tract infections
12. Malignancy; oncological Surgery within 5 years or ongoing antitumoral treatment
13. Ongoing sepsis or endocarditis
14. Patients who have an expected 30-day postoperative mortality greater than 10% as determined by the Principal Investigator
15. Any secondary condition as determined by the investigator that would place the subject at an increased risk or preclude the subject's full compliance with the study procedures, including injuries to the urinary organs and/or external genitals; or severe BPH
16. Unexplained/unexpected gross hematuria as determined by the Investigator
17. Current or planned treatment with an investigational drug (IND), device (IDE), or other investigational intervention within 3 months prior to or during participation in this clinical trial
18. Patients who have a current unrepaired ureteral avulsion as determined by the investigator
19. Patients otherwise contraindicated for urological interventions, including ureter guidewire placement via bladder cystoscopy and ureteral catheterization, or otherwise contraindicated for any of the other study procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
85 Years
Study:
NCT07017933
Study Brief:
Protocol Section:
NCT07017933