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EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03694210
Recruitment Status : Completed
First Posted : October 3, 2018
Results First Posted : November 2, 2021
Last Update Posted : November 2, 2021
Sponsor:
Information provided by (Responsible Party):
Interscope, Inc.

Study Description
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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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
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

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety: Number of Participants With Device Related Complications [ Time Frame: 21 +/- 7 Days ]
    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.


Secondary Outcome Measures :
  1. Effectiveness: Number of Participants With at Least 70% of Necrotic Debris Removed [ 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 follow up visit.

  2. Mean Total Procedure Time to Achieve at Least 70% Reduction in Necrosis [ Time Frame: Completion of all necrosectomy procedures per patient ]

    Assessment of total procedure time to achieve clearance of necrosis for all procedures.

    Total procedure time is measured from scope-in to scope-out. EndoRotor time is measured from the start of EndoRotor use to the end of EndoRotor use.


  3. Adequacy of Procedural Debridement: Mean Percent Necrotic Material Removed From the WOPN Cavity Per Procedure. [ Time Frame: 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. ]
    At the completion of each necrosectomy procedure the Investigator will visually inspect the WOPN cavity endoscopically and estimate the percent of necrosis that was removed from the cavity using EndoRotor. For each procedure, the initial amount of necrosis in the WOPN cavity is considered 100%.

  4. Mean Number of Necrosectomy Procedures Required Per Participant to Achieve at Least 70% Reduction in Necrosis. [ Time Frame: 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. ]
    The total number of necrosectomy procedures required per participant to achieve at least 70% reduction in necrosis from the WOPN will be assessed.

  5. Mean Length of Hospital Stay Per Participant [ Time Frame: At patient discharge from hospital ]
    The total length of hospital stay per participant measured in days, from the date of the index necrosectomy procedure to the date of discharge.

  6. Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score [ Time Frame: 21 +/- 7 Days ]

    The SF-36v1 questionnaire measures functional health and well-being from a patient's point of view. The questionnaire assess eight health domains including: Physical Functioning, Role Limitations due to Physical Health, Role Limitations due to Emotional Problems, Energy/Fatigue, Emotional Well Being, Social Functioning, Pain, and General Health.

    Participants were asked to complete the questionnaire at the Baseline Visit and then again at the 21 Day Post Necrosectomy Follow-up Visit. The results of the questionnaire from the 21 Day Post Necrosectomy Follow-up Visit were then compared to those of Baseline for improvement.

    Numeric scores for each health domain are reported on a scale of 0-100 with improvement demonstrated by a higher score than baseline. Statistically significant improvement is denoted by differences in Baseline and 21 Day Follow-up Visit scores that have a p-value < 0.05.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.
Contacts and Locations
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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
  Study Documents (Full-Text)

Documents provided by Interscope, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] August 31, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Interscope, Inc.
ClinicalTrials.gov Identifier: NCT03694210    
Other Study ID Numbers: CLIN-0047
First Posted: October 3, 2018    Key Record Dates
Results First Posted: November 2, 2021
Last Update Posted: November 2, 2021
Last Verified: October 2021
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
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