← Back to Search

Procedure

Endoscopic Techniques vs. EndoRotor® for Severe Pancreatitis (RESOlVE Trial)

N/A

Recruiting

Led By Marco Bruno, MD PhD

Research Sponsored by Erasmus Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during a 6 month follow up period

Awards & highlights

RESOlVE Trial Summary

This trial is studying a device to treat necrotizing pancreatitis, a severe condition associated with significant morbidity and mortality. Results from previous studies are promising.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include bleeding, infection, or further injury to the pancreas during necrosectomy procedures. The EndoRotor® system's specific risks will be compared against those of standard treatments.

RESOlVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need a special procedure for my pancreas due to severe inflammation.

RESOlVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during a 6 month follow up period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during a 6 month follow up period

This trial's timeline: 3 weeks for screening, Varies for treatment, and during a 6 month follow up period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The number of DEN procedures required to achieve resolution of WON

Secondary outcome measures

Adverse events

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

Debridement time

+6 more

RESOlVE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Interventional armExperimental Treatment1 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 armActive Control1 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Erasmus Medical CenterLead Sponsor

649 Previous Clinical Trials

1,877,643 Total Patients Enrolled

Interscope, Inc.Industry Sponsor

4 Previous Clinical Trials

246 Total Patients Enrolled

1 Trials studying Acute Pancreatitis

30 Patients Enrolled for Acute Pancreatitis

Marco Bruno, MD PhDPrincipal InvestigatorErasmus Medical Center

1 Previous Clinical Trials

30 Total Patients Enrolled

1 Trials studying Acute Pancreatitis

30 Patients Enrolled for Acute Pancreatitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project still open to recruitment?

"Affirmative, this medical trial is actively recruiting as noted on clinicaltrials.gov. It was first published on September 2nd of 2022 and has been updated as recentyly as October 19th of 2023."

Answered by AI

How many participants are enrolling in the current clinical experiment?

"In order to advance this clinical trial, 60 suitable candidates must partake in the study. These test-subjects can enrol at California Pacific Medical Center in San Francisco or Thomas Jefferson University Hospital in Philadelphia."

Answered by AI

In how many settings is this research project being conducted?

"This clinical trial is running at 12 different sites, located in San Francisco, Philadelphia and Hvidovre as well as other cities. To minimise the burden of travelling to a site for participation, it is encouraged that patients select the closest available location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Marco J. Bruno 2022. "Conventional Endoscopic Techniques Versus EndoRotor® System for Necrosectomy of Walled of Necrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04814693.

All > Chronic Pancreatitis