Endoscopic Techniques vs. EndoRotor® for Severe Pancreatitis

(RESOlVE Trial)

Enrolling by invitation at 12 trial locations

Overseen By Charlotte van Veldhuisen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Erasmus Medical Center

Must not be taking: Anti-coagulants

Disqualifiers: Pseudoaneurysm, Coagulation disorders, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Varies per procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool, the EndoRotor® System, against standard methods for treating severe pancreatitis. Severe pancreatitis can cause part of the pancreas to become dead tissue, requiring removal. The EndoRotor® aims to simplify and potentially speed up this process. The trial seeks participants with severe pancreatitis who need an endoscopic procedure (a medical test using a tube with a camera) to remove dead tissue. Participants should have had a stent (a small tube to keep passageways open) in place for at least two days and be able to undergo multiple endoscopic procedures. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve future treatment options.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it mentions that anti-coagulant therapy (except aspirin) must be discontinued. It's best to discuss your specific medications with the trial team.

What prior data suggests that the EndoRotor® System is safe for use in endoscopic procedures?

Research has shown that the EndoRotor® System is generally safe for treating pancreatic walled-off necrosis, a severe inflammation of the pancreas. A review of multiple studies found the EndoRotor to be both safe and effective for this treatment. In one study, most patients needed only about 1.6 sessions on average to see significant improvement, with an 85% reduction in solid debris after just one session.

While more large studies are needed to confirm these results, current data suggest that the EndoRotor is well-tolerated, with no major safety concerns reported in the available studies. The FDA has approved this device, which adds confidence in its safety for these procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EndoRotor® System because it introduces a powered debridement tool for managing severe pancreatitis. Unlike conventional endoscopic techniques that rely on the surgeon’s manual skill with standard instruments, the EndoRotor® offers a more automated approach, potentially increasing precision and efficiency in removing necrotic tissue. The system’s integration of a power console, vacuum pump, and specialized single-use components could lead to more consistent outcomes and reduced procedure time. This innovative technique might improve patient recovery rates by making the process of cleaning out walled-off necrosis more effective.

What evidence suggests that the EndoRotor® System is effective for severe pancreatitis?

This trial will compare the EndoRotor® System with conventional endoscopic techniques for treating pancreatic necrosis. Research has shown that the EndoRotor® Resection System effectively addresses this serious condition, where part of the pancreas dies. Studies have found that this device can safely and efficiently remove dead tissue, potentially reducing the number of procedures and shortening hospital stays. Early results suggest it could be a promising alternative to traditional methods. While conventional techniques also work for this condition, the EndoRotor might reduce side effects. More large-scale studies are needed to confirm these advantages, but initial findings are encouraging. ^{1 2 6 7 8}

Who Is on the Research Team?

Marco Bruno, MD PhD

Principal Investigator

Erasmus Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with severe pancreatitis leading to necrosis who've had a stent in place for at least 2 days and can undergo repeated endoscopic procedures. They must understand the study, consent to it, and be able to attend follow-ups. Excluded are those with large pseudoaneurysms, coagulation issues not managed by stopping anticoagulants (except aspirin), unsafe conditions for endoscopy, pregnant or breastfeeding women without reliable contraception.

Inclusion Criteria

My stent has been in place for at least 2 days before the DEN procedure.

I understand the study's requirements, have given my consent in writing, and can attend all follow-up visits.

I can undergo multiple endoscopies.

Exclusion Criteria

I cannot or do not want to give permission for treatment.

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

I have a pseudoaneurysm larger than 1 cm in my pancreas.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo direct endoscopic necrosectomy (DEN) using either the EndoRotor System or conventional endoscopic techniques

Varies per procedure

Multiple visits for procedures

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

6 months

Follow-up visits at 1, 3, and 6 months post-necrosectomy

What Are the Treatments Tested in This Trial?

Interventions

• Conventional endoscopic devices
• EndoRotor® System

Trial Overview The trial compares two methods of removing dead tissue from the pancreas due to severe inflammation: conventional endoscopic techniques versus a new device called EndoRotor®. It's a randomized controlled trial aiming to see which method is more effective and has fewer complications.

How Is the Trial Designed?

Group I: Interventional arm Experimental Treatment 1 Intervention

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.

Group II: Control arm Active Control 1 Intervention

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 Is Running the Clinical Trial?

Erasmus Medical Center

Lead Sponsor

Trials

742

Recruited

2,156,000+

Interscope, Inc.

Industry Sponsor

Trials

5

Recruited

310+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11419429/

A systematic review and meta-analysis Our study shows that the novel EndoRotor device seems to be safe and effective for treating pancreatic necrosis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9932860/

Endoscopic management of pancreatic walled-off necrosis Overall, with the limited data available, the EndoRotor resection system appears to be safe and effective. Large, randomized trials are required to confirm ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016510721016564

Safety and efficacy of a novel resection system for direct ... The new PED system seems to be a safe and effective treatment tool for WOPN, resulting in fewer interventions and lower hospital duration.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04814693

Conventional Endoscopic Techniques Versus EndoRotor® ... Aim of this study is to assess the performance of the EndoRotor, as compared to conventional endoscopic techniques, for direct endoscopic necrosectomy (DEN) of ...

5. practicalgastro.com practicalgastro.com/2021/11/23/endoscopic-management-of-pancreatic-necrosis-using-the-endorotor-resection-system/

Endoscopic Management of Pancreatic Necrosis Using the ... Overall, with the limited data available, the EndoRotor resection system appears to be safe and effective. However, most studies are limited by ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03694210

EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016510724001317

Safety, efficacy, and clinical utility of the 5.1-mm ... Results from this study showed an average of 1.6 DEN sessions were needed to achieve WON resolution with an 85% single-session reduction in solid debris.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN200016.pdf

DEN200016 summary - accessdata.fda.gov The EndoRotor device is indicated to resect and remove necrotic tissue in symptomatic. Walled off pancreatic necrosis /Walled off necrosis (WOPN/WON) after ...