Conventional Endoscopic Techniques Versus EndoRotor® System for Necrosectomy of Walled of Necrosis

NCT04814693 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: CLIN-0061
• Study Type: interventional
• Target: 60
• Locations: 6 countries
• Sites: 12

Brief Summary

In acute pancreatitis, approximately 20% of the cases result in severe necrotizing pancreatitis which is associated with significant morbidity and mortality. Necrotizing pancreatitis is characterized by the development of an acute necrotic collection and as this collection persists beyond 4 weeks, walled off necrosis (WON) encapsulates the collection. To date, this is treated by the step-up approach, which contains percutaneous drainage and minimally invasive video assisted retroperitoneal debridement (VARD) or endoscopic ultrasound (EUS) guided drainage followed by direct endoscopic necrosectomy (DEN). Different DEN techniques are available for the treatment of WON, however, there is a lack of effective endoscopic instruments to perform DEN. Recently, the first dedicated alternative to conventional DEN has been cleared for use, namely the EndoRotor® Resection System. This device is a powered mechanical debridement device intended for use in endoscopic procedures to resect and remove necrotic debris during DEN for WON. Previous (pilot and feasibility) studies showed promising results in terms of the amount of procedures, adverse events and length of hospital stay. Therefore, aim of this study is to assess the performance of the EndoRotor, as compared to conventional endoscopic techniques, for direct endoscopic necrosectomy (DEN) of walled off necrosis (WON) in a randomized controlled trial.

Conditions

Acute Pancreatitis; Necrosis; Pancreas, Acute (Infectious)

Outcome Measures

Primary Outcomes (1)

• The number of DEN procedures required to achieve resolution of WON

  1. Resolution is defined as clinical improvement of WON symptoms precluding the need for additional endoscopic or surgical interventions. 2. Clinical improvement is defined according to the criteria used in the PANTER trial and TENSION trial.8,15 "Clinical improvement" was defined as: i. Improved function of at least two organ systems (i.e. circulatory, pulmonary, renal) according to the Investigator's medical judgement within 72 hours, or; ii. At least 10% improvement of two out of three parameters of infection (i.e. C-reactive protein, leucocyte count or temperature) within 72 hours.

  During a 6 month follow up period

Secondary Outcomes (9)

• Adverse events

  During a 6 month follow up period

• Conversion to surgery defined as number of subject that require surgical intervention as a result of DEN failure as assessed by the Investigator during the index procedure through the 6 month post necrosectomy follow-up visit

  During a 6 month follow up period

• Length of hospitalization

  During a 6 month follow up period

• Mean total cost of care per subject

  During a 6 month follow up period

• Percent reduction in WON collection volume (cm3)

  During a 6 month follow up period

Study Arms (2)

Interventional arm

EXPERIMENTAL

Subjects randomized to the control device arm will undergo treatment with the EndoRotor System, which is a powered debridement tool intended for use in endoscopic procedures to resect and remove necrotic debris during direct endoscopic necrosectomy (DEN) for walled-off necrosis. The system consists of capital components including a power console, roll stand, vacuum pump, and foot control; as well as disposable components including a single-use catheter, purge kit, and suction bag. The EndoRotor System has CE-Mark 613797 and is cleared for use by the FDA in the United States.

Device: EndoRotor® System (Interscope, Inc., Northbridge, MA USA),

Control arm

ACTIVE COMPARATOR

Subjects randomized to the control device arm will undergo conventional DEN as per the standard of care. Investigators will choose conventional DEN instruments according to their preference.

Procedure: Conventional endoscopic devices (according to standards of care)

Interventions

EndoRotor® System (Interscope, Inc., Northbridge, MA USA), DEVICE

The EndoRotor System is intended for use in endoscopic procedures to resect and remove necrotic debris during DEN for WON. DEN with the EndoRotor System (study device) is considered to be standard of care therapy for patients with WON and not investigational.

Interventional arm

Conventional endoscopic devices (according to standards of care) PROCEDURE

Endoscopic devices used to perform conventional DEN will be chosen according to standard of care and Investigator preference.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage.
• a. Stent must be in place for a minimum of 2 days prior to the DEN procedure.
• Patients who can tolerate repeat endoscopic procedures.
• 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.
• ASA classification \< 5.

You may not qualify if:

• Documented pseudoaneurysm \> 1 cm within the WON.
• Subject unable or unwilling to provide informed consent.
• Intervening gastric varices or unavoidable blood vessels within the WON access tract (visible using endoscopy or endoscopic ultrasound).
• Coagulation disorders or anti-coagulant therapy which cannot be discontinued (aspirin allowed).
• Any condition that in the opinion of the Investigator would create an unsafe clinical situation or stent placement that would not allow the patient to safely undergo an endoscopic procedure.
• 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 enrolled in another trial that could interfere with the endpoint analyses of this trial.
• Prior necrosectomy on existing collection.
• Greater than 2 pancreatic / extra-pancreatic fluid collections.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Interscope, Inc.: collaborator

Study Sites (12)

University of Alabama Medical Center

Birmingham, Alabama, 35294, United States

Location

California Pacific Medical Center

San Francisco, California, 94110, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Copenhagen University Hospital

Hvidovre, Denmark

Location

Evangelical Hospital

Düsseldorf, Germany

Location

University of Frankfurt

Frankfurt, Germany

Location

Humanitas Reserach Hospital & Humanitas University

Milan, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Location

Charlotte van Veldhuisen

Amsterdam, 1076JP, Netherlands

Location

Amsterdam University Medical Center

Amsterdam, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

Central Manchester University Hospital

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Pancreatitis; Necrosis; Communicable Diseases

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Disease Attributes

Study Officials

• Marco Bruno, MD PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Marco Bruno

Model Details: Subjects in this study will be included in either the intervention arm (EndoRotor) of control arm (conventional procedures).

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 24, 2021
• Study Start: September 2, 2022
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); DE (2); IT (2); NL (3); GB (1); DK (1)