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 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT06095050
Eligibility Criteria:
Inclusion Criteria:
1. Male, female, transgender female, transgender male, non-binary
2. Moderate to severe shoulder pain (VAS \> 40)
3. Pain refractory to at least 6 months of physician-directed conservative therapy (analgesics or injections or PT), including a minimum of 6 weeks of PT
4. Willing, able, and mentally competent to provide informed consent and to tolerate angiography and physical therapy
Exclusion Criteria:
1. History of peripheral arterial disease or peripheral artery disease symptoms including claudication, diminished or absent upper/lower extremity pulses, or known upper extremity arterial atherosclerosis or occlusion that would limit selective angiography
2. Known history of anaphylaxis to iodinated contrast agents or gadolinium based contrast
3. Acute kidney injury
4. Allergy to poppy seeds or lipiodol
5. Renal dysfunction as defined by serum creatinine \>1.6 dl/mg or eGFR \<60 obtained within 30 days of procedure.
6. Uncorrectable coagulopathy (platelet count \< 50,000, international normalized ratio \>1.8 within 30 days of procedure
7. Active systemic or local upper extremity infection
8. Patient pregnant, intending to become pregnant during the study.
9. Prior shoulder replacement surgery
10. Prior rotator cuff repair surgery
11. Previous history of complete full-thickness tear of the rotator cuff
12. Presence of non-MRI compatible devices (e.g., non-compatible cardiac pacemaker).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT06095050
Study Brief:
Protocol Section:
NCT06095050