EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Prospective, Trial Evaluating the Safety and Effectiveness of the Interscope Endorotor® System for Direct Endoscopic Necrosectomy of Walled Off Pancreatic Necrosis

Conditions
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Acute Pancreatic Necrosis, Acute Pancreatitis, Necrotizing Pancreatitis

Intervention / Treatment
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* Device: EndoRotor Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are >22; inclusive of males and females. Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage Imaging suggestive of greater than or equal to 30% necrotic material Walled off pancreatic necrosis size ≥6 cm and ≤22cm Subject can tolerate repeated endoscopic procedures Subject capable of giving informed consent. 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: Subject unable to give informed consent. Subject is unwilling to return for repeated endoscopies. Documented Pseudoaneurysm > 1cm within the WOPN Intervening gastric varices or unavoidable blood vessels within the access tract (visible using endoscopy or endoscopic ultrasound). Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure 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). 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. Patient is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EndoRotor Therapy<br>Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis. | Device: EndoRotor Therapy<br>* To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness: Number of Participants With at Least 70% of Necrotic Debris Removed | 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. | 21 +/- 7 Days | 
| Mean Total Procedure Time to Achieve at Least 70% Reduction in Necrosis | 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. | Completion of all necrosectomy procedures per patient | 
| Adequacy of Procedural Debridement: Mean Percent Necrotic Material Removed From the WOPN Cavity Per Procedure. | 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%. | 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. | The total number of necrosectomy procedures required per participant to achieve at least 70% reduction in necrosis from the WOPN will be assessed. | 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 | The total length of hospital stay per participant measured in days, from the date of the index necrosectomy procedure to the date of discharge. | At patient discharge from hospital | 
| Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score | 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. | 21 +/- 7 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Direct Endoscopic Necrosectomy, Walled Off Necrosis, Walled Off Pancreatic Necrosis