An interventional study of EndoRotor® System (Interscope, Inc., Northbridge, MA USA), and Conventional endoscopic devices (according to standards of care) in Acute Pancreatitis and Necrosis; Pancreas, Acute (Infectious), sponsored by Erasmus Medical Center. Enrolling by invitation at 12 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Treatment
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.
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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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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),
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)
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.
Endoscopic devices used to perform conventional DEN will be chosen according to standard of care and Investigator preference.
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.
Time frame: During a 6 month follow up period
Adverse events
The occurrence of all adverse events measured from the Index Procedure through the 6 Month Post Necrosectomy Follow-up Visit
Time frame: 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
In case of conversion to surgery, reason for conversion and type of surgical procedure
Time frame: During a 6 month follow up period
Length of hospitalization
Length of hospitalization measured in days from the Index Procedure, including days in intensive care unit (ICU) vs. standard in-patient hospitalization
Time frame: During a 6 month follow up period
Mean total cost of care per subject
Mean total cost of care per subject including: procedure costs, debridement devices used during the procedure, and inpatient hospital stay from the date of procedure to the date of discharge based on reimbursement fee structure expressed in US dollars, Euros or UK Pounds respectively. a. Procedure costs will be based on the cost of an endoscopic retrograde cholangiopancreatography (ERCP) which covers room, X-ray, sedation, personnel, and other materials.
Time frame: During a 6 month follow up period
Percent reduction in WON collection volume (cm3)
Assessed by contrast enhanced computed tomography (CECT) scan or magnetic resonance imaging (MRI) (Baseline vs. completion of necrosectomy). Percent reduction in WON collection volume (cm3) as assessed by contrast enhanced computed tomography (CECT) scan or magnetic resonance imaging (MRI) (Baseline vs. completion of necrosectomy). 1. Endoscopic ultrasound (EUS) may be used for imaging only when a subject is contraindicated for MRI and CECT. 2. WON collection volume will be measured as follows: i. Length = longest diameter in cm/mm in the axial plane (left - right) ii. Width = the longest diameter in cm/mm (frontal - dorsal) in the same axial plane as the length, perpendicular on the longitudinal axis. iii. Height = longest diameter in cm/mm on coronal plane (cranial - caudal)
Time frame: During a 6 month follow up period
Procedure time
Measured in minutes from the point of per-oral scope insertion to scope removal (scope-in / scope-out).
Time frame: During a 6 month follow up period
Debridement time
Measured in minutes from the start of the debridement procedure to completion of the debridement procedure, including time to swap devices.
Time frame: During a 6 month follow up period
Subject Quality of Life
Subject quality of life (QOL) as assessed by a SF-36 questionnaire performed at Baseline, Discharge, and at the 1, 3, and 6 Month Post Necrosectomy Follow-up Visits.
Time frame: During a 6 month follow up period
The number of device deficiencies, defined as any inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance including malfunction, use errors, and inadequate labelingprocedure
Assessed by the Investigator during each DEN procedure. This may include malfunctions, use error, or inadequacy in the information supplied by the manufacturer
Time frame: During a 6 month follow up period
Plan to share: No
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