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EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial

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ClinicalTrials.gov Identifier: NCT03694210
Recruitment Status : Completed
First Posted : October 3, 2018
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Interscope, Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Acute Pancreatic Necrosis Acute Pancreatitis Necrotizing Pancreatitis Device: EndoRotor Therapy Not Applicable

Detailed Description:

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 with walled off pancreatic necrosis (WOPN). Total enrollment 30 subjects with at least 15 enrolled in the US.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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 with walled off pancreatic necrosis (WOPN).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Trial Evaluating the Safety and Effectiveness of the Interscope Endorotor® System for Direct Endoscopic Necrosectomy of Walled Off Pancreatic Necrosis
Actual Study Start Date : November 15, 2018
Actual Primary Completion Date : August 22, 2019
Actual Study Completion Date : August 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: EndoRotor Therapy
Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.
Device: 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.




Primary Outcome Measures :
  1. Safety: Rate of major complications [ Time Frame: 21 +/- 7 Days ]
    The primary endpoint of this study is the freedom from major 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.


Secondary Outcome Measures :
  1. Effectiveness: Percentage of necrosis removed measured by CT Scan [ Time Frame: 21 +/- 7 Days ]
    Successful clearance of necrosis in the collection being treated during direct endoscopic necrosectomy where success is defined as at least 70% of the necrotic debris in the collection being treated is removed based on CT evaluation of the cavity at the 21 (+/-7) day day follow up visit.

  2. Procedure Time: Record each procedure time [ Time Frame: 14 Days ]
    Assessment of total procedure time to achieve clearance of necrosis for all procedures.

  3. Adequacy of Procedural Debridement: Visual estimation of percent removal of necrosis from the site based on endoscopic view [ Time Frame: 14 Days ]
    At conclusion of the procedure, the percent removal of the total necrosis present will be visually estimated by the Investigator as a measure of removal adequacy with the EndoRotor

  4. Number of Procedures: Record total number of procedures to achieve clearance [ Time Frame: 14 Days ]
    Assessment of total number of procedures to achieve clearance of necrosis.

  5. Hospital Resource Utilization: Total length of hospital stay [ Time Frame: 21 +/- 7 Days ]
    The total length of hospital stay measured from the first use of the EndoRotor to study exit at the 21 day follow up visit will be used to determine potential economic advantages of the EndoRotor procedure.

  6. Quality of Life - SF-36v2 Health Survey, Physical Composite Score [ Time Frame: 21 +/- 7 Days ]
    Evaluation of Physical Component Score for improved quality of life. Score will be reported on a scale of 0-100 with improvement demonstrated by a higher score above the mean value of 50

  7. Quality of Life - SF-36v2 Health Survey, Mental Composite Score [ Time Frame: 21 +/- 7 Days ]
    Evaluation of Mental Component Score for improved quality of life. Score will be reported on a scale of 0-100 with improvement demonstrated by a higher score above the mean value of 50



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694210


Locations
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United States, Arkansas
Benjamin Tharian
Little Rock, Arkansas, United States, 72205
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94304
California Pacific Medical Center - Sutter Health
San Francisco, California, United States, 94115
United States, Illinois
University of Chicago Department of Medicine
Chicago, Illinois, United States, 60637
United States, New Jersey
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
United States, New York
Arvin Trindade
Queens, New York, United States, 11040
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Germany
University of Frankfurt Medicine
Frankfurt, Germany, 60590
Interdisciplinary Clinic for Endoscopy - TU Munich
München, Germany, 81675
Netherlands
Erasmus Medical Center
Rotterdam, Netherlands, 3015 CE
Sponsors and Collaborators
Interscope, Inc.
Investigators
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Principal Investigator: Marco Bruno, MD PhD Erasmus Medical Center

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Responsible Party: Interscope, Inc.
ClinicalTrials.gov Identifier: NCT03694210     History of Changes
Other Study ID Numbers: CLIN-0047
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Interscope, Inc.:
Direct Endoscopic Necrosectomy
Walled Off Necrosis
Walled Off Pancreatic Necrosis
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Acute Necrotizing
Necrosis
Pancreatic Diseases
Digestive System Diseases
Pathologic Processes