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 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT01419769
Eligibility Criteria:
Inclusion Criteria:
* (patients must meet all criteria)
1. Age between 18 and 75 years old, male or female.
2. Eligible for endoscopic intervention.
3. Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage
4. Symptomatic pancreatic pseudocyst having the following characteristics:
* Greater than or equal to 6 cm in size (based upon the maximum crosssectional area in the CT scan),
* Adherent to bowel wall, and
* ≥70% fluid content
5. Patient understands the study requirements and the treatment procedures and provides written Informed Consent using a form that has been approved by the local Institutional Review Board or Ethics Committee before any study-specific tests or procedures are performed.
6. Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study.
Exclusion Criteria:
* (patients meeting any of the below criteria will be excluded from study)
1. \<18 or \>75 years of age
2. Pancreatic pseudocysts having the following characteristics:
* Require nasocystic drainage,
* \< 69% fluid content
3. The fluid collection to be drained is an immature pseudocyst
4. The fluid collection to be drained is a cystic neoplasm
5. The fluid collection to be drained is a pseudoaneurysm
6. The fluid collection to be drained is a duplication cyst
7. The fluid collection to be drained is a non-inflammatory fluid collection
8. There is more than one pseudocyst requiring drainage
9. Abnormal coagulation:
* INR \> 1.5 and not correctable
* presence of a bleeding disorder
* platelets \< 50,000/mm3
10. Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis).
11. Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound)
12. Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient.
13. Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study.
14. Currently participating in another investigational drug of device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01419769
Study Brief:
Protocol Section:
NCT01419769