Sponsor study identifier
interventional
30
3 countries
10
Study Start
November 15, 2018
Actual (reported)Primary Completion
August 22, 2019
Actual (reported)Study Completion
August 22, 2019
Actual (reported)A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy (DEN) with walled off pancreatic necrosis (WOPN).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 22, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 26, 2018
Actual (reported)October 3, 2018
Actual (reported)November 15, 2018
Actual (reported)August 22, 2019
Actual (reported)August 22, 2019
Actual (reported)November 2, 2021
Actual (reported)Safety: Number of Participants With Device Related Complications
The primary endpoint of this study is the freedom from major device related complications. The safety endpoint will include an assessment of the safety of the EndoRotor when performing endoscopic necrosectomy. For the purpose of this study, the safety evaluation shall include complications associated with endoscopic necrosectomy through the 21 (+/-7) day follow-up period. Potential endoscopic complications include perforation and bleeding.
21 +/- 7 Days
Effectiveness: Number of Participants With at Least 70% of Necrotic Debris Removed
21 +/- 7 Days
Mean Total Procedure Time to Achieve at Least 70% Reduction in Necrosis
Completion of all necrosectomy procedures per patient
Adequacy of Procedural Debridement: Mean Percent Necrotic Material Removed From the WOPN Cavity Per Procedure.
This outcome was assessed at the completion each necrosectomy procedure per participant. At the completion of all necrosectomy procedures for all participants, an overall mean percent necrotic material removed from the WOPN per procedure was calculated.
Mean Number of Necrosectomy Procedures Required Per Participant to Achieve at Least 70% Reduction in Necrosis.
This outcome was assessed at completion of all necrosectomy procedures per participant. After completion of all necrosectomy procedures in all participants the overall mean number of procedures to achieve at least 70% reduction in necrosis was calculated.
Mean Length of Hospital Stay Per Participant
At patient discharge from hospital
Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.
To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Benjamin Tharian
Little Rock, Arkansas, 72205, United States
Stanford University Medical Center
Palo Alto, California, 94304, United States
California Pacific Medical Center - Sutter Health
San Francisco, California, 94115, United States
University of Chicago Department of Medicine
Chicago, Illinois, 60637, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
Arvin Trindade
Queens, New York, 11040, United States
Thomas Jefferson University
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.
Marco Bruno, MD PhD
Erasmus Medical Center
30 participants (actual enrollment reported by the registry).
First Submitted
September 26, 2018
First Posted
October 3, 2018
Study Start
November 15, 2018
Pancreatitis - Microbiome As Predictor of Severity
Contact the study team to confirm eligibility.
Philadelphia, Pennsylvania, 19107, United States
University of Frankfurt Medicine
Frankfurt, 60590, Germany
Interdisciplinary Clinic for Endoscopy - TU Munich
München, 81675, Germany
Erasmus Medical Center
Rotterdam, 3015 CE, Netherlands
Primary Completion
August 22, 2019
Actual (reported)Study Completion
August 22, 2019
Actual (reported)Last Updated
November 2, 2021
Results First Posted
November 2, 2021
Record last verified: 2021-10
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Source: ClinicalTrials.gov.
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