Status:
ENROLLING_BY_INVITATION
Conventional Endoscopic Techniques Versus EndoRotor® System for Necrosectomy of Walled of Necrosis
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Interscope, Inc.
Conditions:
Acute Pancreatitis
Necrosis; Pancreas, Acute (Infectious)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In acute pancreatitis, approximately 20% of the cases result in severe necrotizing pancreatitis which is associated with significant morbidity and mortality. Necrotizing pancreatitis is characterized ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04814693
Start Date
September 2 2022
End Date
February 1 2027
Last Update
August 8 2025
Active Locations (12)
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1
University of Alabama Medical Center
Birmingham, Alabama, United States, 35294
2
California Pacific Medical Center
San Francisco, California, United States, 94110
3
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
4
Copenhagen University Hospital
Hvidovre, Denmark