Acute PancreatitisRESOlVENCT04814693
Conventional Endoscopic Techniques Versus EndoRotor® System for Necrosectomy of Walled of Necrosis
A study testing EndoRotor® System (Interscope, Inc., Northbridge, MA USA), and Conventional endoscopic devices (according to standards of care) in people with Acute Pancreatitis and Necrosis; Pancreas, Acute (Infectious), run by Erasmus Medical Center at 12 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis, Necrosis; Pancreas, Acute (Infectious)
- What is being tested?
- EndoRotor® System (Interscope, Inc., Northbridge, MA USA), and Conventional endoscopic devices (according to standards of care)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 2 Sep 2022to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 6 countries
United States3 sites
University of Alabama Medical Center
Birmingham, Alabama, 35294
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
California Pacific Medical Center
San Francisco, California, 94110
Netherlands3 sites
Charlotte van Veldhuisen
Amsterdam, 1076JP
Amsterdam University Medical Center
Amsterdam
St. Antonius Hospital
Nieuwegein
Germany2 sites
Evangelical Hospital
Düsseldorf
University of Frankfurt
Frankfurt
Italy2 sites
Humanitas Reserach Hospital & Humanitas University
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma
About this study
Official title: A Prospective, Post-Market, Multicenter, Randomized Controlled Trial to Compare the Performance of the EndoRotor® System Versus Conventional Endoscopic Techniques for Direct Endoscopic Necrosectomy of Walled Off Necrosis - The RESOlVE Trial
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.
- Being tested
- EndoRotor® System (Interscope, Inc., Northbridge, MA USA),, Conventional endoscopic devices (according to standards of care)
- Medical subject headings
- Pancreatitis, Necrosis, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Conventional endoscopic devices (according to standards of care)Procedure or surgery
Endoscopic devices used to perform conventional DEN will be chosen according to standard of care and Investigator preference.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional endoscopic devices (according to standards of care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of DEN procedures required to achieve resolution of WON
- Resolution is defined as clinical improvement of WON symptoms precluding the need for additional endoscopic or surgical interventions.
- Clinical improvement is defined according to the criteria used in the PANTER trial and TENSION trial.8,15 "Clinical improvement" was defined as:
- 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.
Measured: During a 6 month follow up period
Secondary outcomes (9)
Adverse events
The occurrence of all adverse events measured from the Index Procedure through the 6 Month Post Necrosectomy Follow-up Visit
Measured: 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
Measured: 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
Measured: 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.
- Procedure costs will be based on the cost of an endoscopic retrograde cholangiopancreatography (ERCP) which covers room, X-ray, sedation, personnel, and other materials.
Measured: 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).
- Endoscopic ultrasound (EUS) may be used for imaging only when a subject is contraindicated for MRI and CECT.
- WON collection volume will be measured as follows:
- 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)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: During a 6 month follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start2 Sep 2022
- Primary completion28 Aug 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects in this study will be included in either the intervention arm (EndoRotor) of control arm (conventional procedures).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Interscope, Inc.
- Responsible party
- Principal investigator, Marco J. Bruno, Erasmus Medical Center
- Investigators
- Marco Bruno, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814693
- Sponsor's protocol ID
- CLIN-0061
- Acronym
- RESOlVE
- Status last verified
- Aug 2025
- First submitted
- 18 Mar 2021
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Post-Market, Multicenter, Randomized Controlled Trial to Compare the Performance of the EndoRotor® System Versus Conventional Endoscopic Techniques for Direct Endoscopic Necrosectomy of Walled Off Necrosis - The RESOlVE Trial
- ClinicalTrials.gov ID
- NCT04814693
- Acronym / sponsor ID
- RESOlVE / CLIN-0061
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Interscope, Inc.
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 28 Aug 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects in this study will be included in either the intervention arm (EndoRotor) of control arm (conventional procedures).
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Device: EndoRotor® System (Interscope, Inc., Northbridge, MA USA),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. |
| Control arm | Active comparator | Procedure: Conventional endoscopic devices (according to standards of care)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoRotor® System (Interscope, Inc., Northbridge, MA USA),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. | Device | Interventional arm |
| Conventional endoscopic devices (according to standards of care)Endoscopic devices used to perform conventional DEN will be chosen according to standard of care and Investigator preference. | Procedure or surgery | Control arm |
Primary outcome
The number of DEN procedures required to achieve resolution of WON
Time frame: During 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.
9 secondary outcomes
Adverse events
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
Time frame: During a 6 month follow up period
Length of hospitalization
Time frame: During a 6 month follow up period
Mean total cost of care per subject
Time frame: During a 6 month follow up period
Percent reduction in WON collection volume (cm3)
Time frame: During a 6 month follow up period
Procedure time
Time frame: During a 6 month follow up period
Debridement time
Time frame: During a 6 month follow up period
Subject Quality of Life
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
Time frame: During a 6 month follow up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marco Bruno, MD PhD principal investigator
Erasmus Medical Center
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoRotor® System (Interscope, Inc., Northbridge, MA USA), and Conventional endoscopic devices (according to standards of care) in people with Acute Pancreatitis and Necrosis; Pancreas, Acute (Infectious), run by Erasmus Medical Center at 12 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Netherlands, Germany, Italy, Denmark and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of DEN procedures required to achieve resolution of WON (time frame: During a 6 month follow up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.