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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Erasmus Medical Center
Study ID
NCT04814693
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
    Endoscopic devices used to perform conventional DEN will be chosen according to standard of care and Investigator preference.

Study Details

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.

Key Dates

Start date
Sep 2, 2022
Status verified
Aug 2025
Primary completion
Aug 28, 2026
Completion
Feb 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Interventional arm
    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.
  • Active Comparator: Control arm
    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.

Primary Outcome Measure

The number of DEN procedures required to achieve resolution of WON [ Time Frame: During a 6 month follow up period ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Alabama Medical CenterBirminghamAlabama35294-
California Pacific Medical CenterSan FranciscoCalifornia94110-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-

Find similar trials in Birmingham, AL

By research site
University of Alabama Medical Center· Birmingham, ALCalifornia Pacific Medical Center· San Francisco, CAThomas Jefferson University Hospital· Philadelphia, PA

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