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 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT04234035
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-55,
2. with acute flank pain - for whom clinician believes acute flank pain may be from renal colic
3. who are deemed by the treating clinician to be at low risk for dangerous alternative diagnoses.
4. Clinician is considering imaging patient for kidney stones (any imaging)
Exclusion Criteria:
1. Recent trauma related to pain (including minor such as lifting/turning)
2. Pregnancy (previous or discovered during ED visit)
3. Recent surgical procedure on abdomen or pelvis (30d)
4. Recent urologic procedure (30d)
5. Recent childbirth (30d)
6. Signs of Systemic Infection: Fever \>100.9 (101 and up), SBP \<90, HR\>120
7. Moderate or severe abdominal tenderness or rebound/guarding, consistently present (present for more than one exam, or present after patient treated with pain medication)
8. Second doctor's visit (ED, PCP, urgent care) for THIS episode of pain (previous similar visits ok if pain gone for \>30d in between episodes) (if seen at PCP or urgent care in same day or 24 hour period, this is not an exclusion, but if seen at PCP/urgent care or ED 1-30 days prior to index visit, with same pain, excluded)
9. Known history of one kidney or other urological/renal abnormality (including neurogenic bladder, ESRD and paraplegia; or if solitary kidney discovered on US)
10. Known malignancy (any) within past year (or received treatment in the past 12 months)
11. Immunocompromised (chronic steroids, HIV, crohns, immunomodulators or severely ill chronically)
12. On anticoagulation
13. Crisis patient (behavioral health)/belligerent
14. Lacks capacity for medical decision-making
15. Unlikely to respond to follow-up calls (IVDA, homeless, no phone)
16. Clinician is concerned for alternative diagnosis requiring CT scan (appendicitis) (\>5% likelihood by clinician gestalt)
17. Patient is not improving clinically and clinician is considering admission
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04234035
Study Brief:
Protocol Section:
NCT04234035