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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT06553651
Eligibility Criteria:
Inclusion Criteria:
* Subjects aged 18 years and above, inclusive of both males and females.
* Patients with symptomatic pancreatic necrosis resulting from acute pancreatitis, indicated for endoscopic necrosectomy following endoscopic ultrasound (EUS)-guided drainage.
* Imaging indicative of ≥30% necrotic material within the pancreas.
* Walled-off pancreatic necrosis (WOPN) size ≥6 cm.
* Subjects able to tolerate repeated endoscopic procedures.
* Capacity for providing informed consent.
* Understanding of study requirements, provision of written informed consent, and willingness and ability to attend required follow-up assessments through 21 (+/- 7) days.
Exclusion Criteria:
* Inability to provide informed consent.
* Unwillingness to undergo repeated endoscopies.
* Presence of documented Pseudoaneurysm \> 1cm within the WOPN.
* Intervening gastric varices or unavoidable blood vessels within the access tract.
* Use of dual antiplatelet therapy or therapeutic anticoagulation that cannot be temporarily discontinued.
* Any condition deemed by the investigator to compromise the safety of undergoing an endoscopic procedure.
* Pregnancy, lactation, or absence of reliable contraception in women of childbearing potential.
* Current enrollment in another investigational trial with potential to interfere with this study's endpoint analyses.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06553651
Study Brief:
Protocol Section:
NCT06553651