Clinical trial NCT03694210: EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial
Official title: Prospective, Trial Evaluating the Safety and Effectiveness of the Interscope Endorotor® System for Direct Endoscopic Necrosectomy of Walled Off Pancreatic Necrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pancreatic Necrosis
Acute Pancreatitis
Necrotizing Pancreatitis
Keywords: Direct Endoscopic Necrosectomy
Walled Off Necrosis
Walled Off Pancreatic Necrosis
Lead sponsor: Interscope, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-03
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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).
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: Safety: Number of Participants With Device Related Complications
timeFrame: 21 +/- 7 Days
Secondary outcomes:
measure: Effectiveness: Number of Participants With at Least 70% of Necrotic Debris Removed
timeFrame: 21 +/- 7 Days
measure: Mean Total Procedure Time to Achieve at Least 70% Reduction in Necrosis
timeFrame: Completion of all necrosectomy procedures per patient
measure: Adequacy of Procedural Debridement: Mean Percent Necrotic Material Removed From the WOPN Cavity Per Procedure.
timeFrame: 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.
measure: Mean Number of Necrosectomy Procedures Required Per Participant to Achieve at Least 70% Reduction in Necrosis.
timeFrame: 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.
measure: Mean Length of Hospital Stay Per Participant
timeFrame: At patient discharge from hospital
measure: Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score
timeFrame: 21 +/- 7 Days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Benjamin Tharian
state: Arkansas
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center - Sutter Health
state: California
city: Chicago
country: United States
facility: University of Chicago Department of Medicine
state: Illinois
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
city: Queens
country: United States
facility: Arvin Trindade
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Frankfurt
country: Germany
facility: University of Frankfurt Medicine
city: München
country: Germany
facility: Interdisciplinary Clinic for Endoscopy - TU Munich
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Erasmus Medical Center
name: Marco Bruno, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.