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:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 1:21 AM
NCT ID:
NCT04814693
Eligibility Criteria:
Inclusion Criteria:
* Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage.
a. Stent must be in place for a minimum of 2 days prior to the DEN procedure.
* Patients who can tolerate repeat endoscopic procedures.
* Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments.
* ASA classification \< 5.
Exclusion Criteria:
* Documented pseudoaneurysm \> 1 cm within the WON.
* Subject unable or unwilling to provide informed consent.
* Intervening gastric varices or unavoidable blood vessels within the WON access tract (visible using endoscopy or endoscopic ultrasound).
* Coagulation disorders or anti-coagulant therapy which cannot be discontinued (aspirin allowed).
* Any condition that in the opinion of the Investigator would create an unsafe clinical situation or stent placement that would not allow the patient to safely undergo an endoscopic procedure.
* Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.
* Patient is enrolled in another trial that could interfere with the endpoint analyses of this trial.
* Prior necrosectomy on existing collection.
* Greater than 2 pancreatic / extra-pancreatic fluid collections.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04814693
Study Brief:
Protocol Section:
NCT04814693