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

Primary Purpose

Acute Pancreatitis, Necrosis; Pancreas, Acute (Infectious)

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
EndoRotor® System (Interscope, Inc., Northbridge, MA USA),
Conventional endoscopic devices (according to standards of care)
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

    a. 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Alabama Medical Center
  • California Pacific Medical Center
  • Thomas Jefferson University Hospital
  • Copenhagen University Hospital
  • Evangelical HospitalRecruiting
  • University of Frankfurt
  • Humanitas Reserach Hospital & Humanitas University
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Charlotte van Veldhuisen
  • Amsterdam University Medical CenterRecruiting
  • St. Antonius HospitalRecruiting
  • Central Manchester University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional arm

Control arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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: 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.

Secondary Outcome Measures

Adverse events
The occurrence of all adverse events measured from the Index Procedure through the 6 Month Post Necrosectomy Follow-up Visit
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
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
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. a. Procedure costs will be based on the cost of an endoscopic retrograde cholangiopancreatography (ERCP) which covers room, X-ray, sedation, personnel, and other materials.
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: i. 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)
Procedure time
Measured in minutes from the point of per-oral scope insertion to scope removal (scope-in / scope-out).
Debridement time
Measured in minutes from the start of the debridement procedure to completion of the debridement procedure, including time to swap devices.
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.
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

Full Information

First Posted
March 18, 2021
Last Updated
October 19, 2023
Sponsor
Erasmus Medical Center
Collaborators
Interscope, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04814693
Brief Title
Conventional Endoscopic Techniques Versus EndoRotor® System for Necrosectomy of Walled of Necrosis
Acronym
RESOlVE
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2022 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
Interscope, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis, Necrosis; Pancreas, Acute (Infectious)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects in this study will be included in either the intervention arm (EndoRotor) of control arm (conventional procedures).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EndoRotor® System (Interscope, Inc., Northbridge, MA USA),
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional endoscopic devices (according to standards of care)
Intervention Description
Endoscopic devices used to perform conventional DEN will be chosen according to standard of care and Investigator preference.
Primary Outcome Measure Information:
Title
The number of DEN procedures required to achieve resolution of WON
Description
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: 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.
Time Frame
During a 6 month follow up period
Secondary Outcome Measure Information:
Title
Adverse events
Description
The occurrence of all adverse events measured from the Index Procedure through the 6 Month Post Necrosectomy Follow-up Visit
Time Frame
During a 6 month follow up period
Title
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
Description
In case of conversion to surgery, reason for conversion and type of surgical procedure
Time Frame
During a 6 month follow up period
Title
Length of hospitalization
Description
Length of hospitalization measured in days from the Index Procedure, including days in intensive care unit (ICU) vs. standard in-patient hospitalization
Time Frame
During a 6 month follow up period
Title
Mean total cost of care per subject
Description
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. a. Procedure costs will be based on the cost of an endoscopic retrograde cholangiopancreatography (ERCP) which covers room, X-ray, sedation, personnel, and other materials.
Time Frame
During a 6 month follow up period
Title
Percent reduction in WON collection volume (cm3)
Description
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: i. 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)
Time Frame
During a 6 month follow up period
Title
Procedure time
Description
Measured in minutes from the point of per-oral scope insertion to scope removal (scope-in / scope-out).
Time Frame
During a 6 month follow up period
Title
Debridement time
Description
Measured in minutes from the start of the debridement procedure to completion of the debridement procedure, including time to swap devices.
Time Frame
During a 6 month follow up period
Title
Subject Quality of Life
Description
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.
Time Frame
During a 6 month follow up period
Title
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
Description
Assessed by the Investigator during each DEN procedure. This may include malfunctions, use error, or inadequacy in the information supplied by the manufacturer
Time Frame
During a 6 month follow up period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage. a. 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Bruno, MD PhD
Phone
+31107035946
Email
m.bruno@erasmusmc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte van Veldhuisen, MD
Phone
+31204446303
Email
c.l.vanveldhuisen@amsterdamumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Bruno, MD PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. A. Ahmed
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. K. Binmoeller
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. T Kowalski
Facility Name
Copenhagen University Hospital
City
Hvidovre
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
Evangelical Hospital
City
Düsseldorf
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. T Beyna
Facility Name
University of Frankfurt
City
Frankfurt
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Mireen Friedrich-Rust
Facility Name
Humanitas Reserach Hospital & Humanitas University
City
Milano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. A. Repici
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. A. Larghi
Facility Name
Charlotte van Veldhuisen
City
Amsterdam
ZIP/Postal Code
1076JP
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte van Veldhuisen, MD
Phone
+31611295139
Email
c.l.vanveldhuisen@amsterdamumc.nl
Facility Name
Amsterdam University Medical Center
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr R.P. Voermans
Facility Name
St. Antonius Hospital
City
Nieuwegein
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. R. Verdonk
Facility Name
Central Manchester University Hospital
City
Manchester
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. J. Geraghty

12. IPD Sharing Statement

Plan to Share IPD
No

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

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