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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07358351
Eligibility Criteria:
Inclusion Criteria:
For all procedures:
* Age ≥ 18 years
* Subject or legal representative is willing and able to provide informed consent
* Subject is willing and able to comply with protocol follow-up
* Elective procedure (non-emergent)
For organ access procedures, one of the following must apply:
* Subjects for whom a percutaneous renal access for nephrostomy tube placement or percutaneous nephrolithotomy have has been indicated
* Subjects for whom a percutaneous biopsy have has been indicated
* Subjects for whom a percutaneous drainage (e.g. paracentesis, thoracentesis, etc.) have has been indicated
For vascular access procedures:
• Subjects for whom a vascular access (arterial or venous) have been indicated
For pain management injections procedures:
• Subjects for whom a pain management injection procedure has been indicated, such as intra-articular injection, nerve block pre- or post- operatively, and epidural
Exclusion Criteria:
* For all procedures:
* Subject refusal
* Subject is unstable or potentially unstable
* Known significant coagulopathy (INR \>2.0, platelet count \<100,000 / µL)
* Previous failed attempt of same procedure
* Suspected infection at intended needle insertion or target site
* BMI \>35 kg/m²
* Subject has any other medical, social, or psychological problem that, in the opinion of the Investigator, precludes them from participating
* Subject who is pregnant or intends to become pregnant during the study
* Hypertension (subject blood pressure ≥180/110mmHg)
* History of venous thrombosis
For organ access procedures:
* Known anatomic abnormalities of target organ
* Subject underwent transplant or urinary diversion
* Abnormal kidney function
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07358351
Study Brief:
Protocol Section:
NCT07358351