Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-11-15
2019-08-22
Brief Summary
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Detailed Description
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Subjects will be debrided with the EndoRotor either at the time of stent placement or post placement at Investigator's discretion with a maximum of 4 EndoRotor procedures. A minimum of 2 days is required between each EndoRotor procedure and all procedures need to be completed within a 14 (+7/-0) day period. Follow up is completed 21 (+/- 7) days after last EndoRotor debridement procedure.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EndoRotor Therapy
Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.
EndoRotor Therapy
To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.
Interventions
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EndoRotor Therapy
To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.
Eligibility Criteria
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Inclusion Criteria
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
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.
22 Years
ALL
No
Sponsors
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Interscope, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Marco Bruno, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Benjamin Tharian
Little Rock, Arkansas, United States
Stanford University Medical Center
Palo Alto, California, United States
California Pacific Medical Center - Sutter Health
San Francisco, California, United States
University of Chicago Department of Medicine
Chicago, Illinois, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Arvin Trindade
Queens, New York, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Frankfurt Medicine
Frankfurt, , Germany
Interdisciplinary Clinic for Endoscopy - TU Munich
München, , Germany
Erasmus Medical Center
Rotterdam, , Netherlands
Countries
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References
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Stassen PMC, de Jonge PJF, Bruno MJ, Koch AD, Trindade AJ, Benias PC, Sejpal DV, Siddiqui UD, Chapman CG, Villa E, Tharian B, Inamdar S, Hwang JH, Barakat MT, Andalib I, Gaidhane M, Sarkar A, Shahid H, Tyberg A, Binmoeller K, Watson RR, Nett A, Schlag C, Abdelhafez M, Friedrich-Rust M, Schlachterman A, Chiang AL, Loren D, Kowalski T, Kahaleh M. Safety and efficacy of a novel resection system for direct endoscopic necrosectomy of walled-off pancreas necrosis: a prospective, international, multicenter trial. Gastrointest Endosc. 2022 Mar;95(3):471-479. doi: 10.1016/j.gie.2021.09.025. Epub 2021 Sep 22.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CLIN-0047
Identifier Type: -
Identifier Source: org_study_id