Back to search results

Comparing EndoRotor® System to Conventional Endoscopic Techniques for Walled-Off Necrosis

This study is comparing two ways to treat walled-off necrosis (WON), a complication of severe acute pancreatitis. WON is a collection of dead tissue that forms after pancreatitis. The study will compare the EndoRotor® System, a device designed to remove this dead tissue, with conventional endoscopic devices. Both methods involve direct endoscopic necrosectomy (DEN), a procedure where doctors use an endoscope to remove the necrotic tissue. You may be able to join if you are 18 or older, have symptomatic pancreatic necrosis from acute pancreatitis, and have already had EUS-guided drainage (a procedure to drain the collection). The study aims to see which method requires fewer DEN procedures to clear up the WON over a 6-month period. The study status is currently unclear.

Study design
This is an interventional study planning to enroll 60 participants. It compares the EndoRotor® System to conventional endoscopic devices for treating walled-off necrosis.
What's involved
You would undergo direct endoscopic necrosectomy (DEN) procedures using either the EndoRotor® System or conventional endoscopic devices. You must be able to tolerate repeat endoscopic procedures.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months to see how many DEN procedures are needed to resolve the walled-off necrosis.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04814693

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

Enrolling by Invitation
NAAges 18+InterventionalTreatment
Erasmus Medical Center
~60 participants
Updated 2025-08-08 on ClinicalTrials.gov
What's tested:EndoRotor® System (Interscope, Inc., Northbridge, MA USA),Conventional endoscopic devices (according to standards of care)

At a glance

Recruiting sites
0 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of DEN procedures required to achieve resolution of WON
Measured over During a 6 month follow up period

Conditions

Acute Pancreatitis
Necrosis; Pancreas, Acute (Infectious)

Explore related trials

Acute PancreatitisWalled Off Necrosis

Where it's being run

12 sites across 8 states
Netherlands3
Germany2
Italy2
Alabama1
California1
Pennsylvania1
Denmark1
United Kingdom1

Study leadership

  • Marco Bruno, MD PhD · PRINCIPAL_INVESTIGATOR · Erasmus Medical Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage.
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.

Exclusion

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.

What this trial measures

  • The number of DEN procedures required to achieve resolution of WONDuring a 6 month follow up period

    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.