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 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT06394869
Eligibility Criteria:
Inclusion Criteria:
1. Patient is referred for assessment of microhematuria (MH) with presentation confirmed by urine microscopy of 3 or more red blood cells per high powered field (RBC/HPF) (documented by the referring physician or at the investigator site) within 6-months of enrollment.
2. Physically able to provide a voided urine sample from a bladder that has not been surgically altered.
3. Able to give informed, written consent.
4. Able and willing to comply with study requirements.
5. Must be 19 or the legal age of consent in the jurisdiction in which the study is taking place to 88 years of age inclusive, at the time of signing the informed consent.
6. Ability to comprehend written and spoken English sufficiently to independently follow all study procedures. Or ability to comprehend Spanish with access to an English-Spanish interpreter for all study related verbal instructions and discussions.
Exclusion Criteria:
1. Prior history of bladder malignancy.
2. Prior history of upper tract UC or prostatic urethral UC.
3. Gross hematuria within the last twelve months (reported in patient's records and/or during patient's interview)
4. Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch)
5. Indication to recommend cystoscopy other than MH (e.g., bothersome benign prostatic hyperplasia symptoms and desires a procedure, weak stream with concerns for urethral stricture).
6. Cystoscopy contraindicated due to another condition or anatomy.
7. History of pelvic radiation.
8. Currently receiving systemic chemotherapy or has had systemic chemotherapy within the last 6 weeks.
9. History of schistosomiasis.
10. History of chronic (\>3 months) indwelling Foley catheter or chronic (\>3 months) bladder stones.
11. Known current pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
88 Years
Study:
NCT06394869
Study Brief:
Protocol Section:
NCT06394869