NL-OMON47969
Not yet recruiting
Not Applicable
PROSPECTIVE, TRIAL EVALUATING THE SAFETY AND EFFECTIVENESS OF THE INTERSCOPE ENDOROTOR® RESECTION SYSTEM FOR DIRECT ENDOSCOPIC NECROSECTOMY OF WALLED OFF PANCREATIC NECROSIS - ENDOROTOR DEN TRIA
Interscope Medical, Inc.0 sites5 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- encapsulated pancreatic necrosis
- Sponsor
- Interscope Medical, Inc.
- Enrollment
- 5
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subjects who are \>22; inclusive of males and females.
- •2\. Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication
- •to undergo endoscopic necrosectomy after having undergone EUS\-guided drainage
- •3\. Imaging suggestive of greater than or equal to 30% necrotic material
- •4\. Walled off pancreatic necrosis size \*6 cm and \*22cm
- •5\. Subject can tolerate repeated endoscopic procedures
- •6\. Subject capable of giving informed consent.
- •7\. 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 through 21 (\+/\- 7\)
- •days, as indicated.
Exclusion Criteria
- •1\. Subject unable to give informed consent.
- •2\. Subject is unwilling to return for repeated endoscopies.
- •3\. Documented Pseudoaneurysm \> 1cm within the WOPN
- •4\. Intervening gastric varices or unavoidable blood vessels within the access tract (visible using
- •endoscopy or endoscopic ultrasound).
- •5\. Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure
- •6\. Any condition that in the opinion of the investigator would create an unsafe clinical situation that would not
- •allow the patient to safely undergo an endoscopic procedure (lack of medical clearance).
- •7\. 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
Outcomes
Primary Outcomes
Not specified
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