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 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•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.

•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
•duration of study participation.
•8. Patient is known to be currently enrolled in another investigational trial that could interfere with the
•endpoint analyses of this trial.

发起方

Interscope Medical, Inc.