EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial

NCT03694210 | Completed Results DMC FDA Device

• 1 other identifier: CLIN-0047
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 10

Brief Summary

A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy (DEN) with walled off pancreatic necrosis (WOPN).

Conditions

Acute Pancreatic Necrosis; Acute Pancreatitis; Necrotizing Pancreatitis

Keywords

Direct Endoscopic Necrosectomy; Walled Off Necrosis; Walled Off Pancreatic Necrosis

Outcome Measures

Primary Outcomes (1)

• Safety: Number of Participants With Device Related Complications

  The primary endpoint of this study is the freedom from major device related complications. The safety endpoint will include an assessment of the safety of the EndoRotor when performing endoscopic necrosectomy. For the purpose of this study, the safety evaluation shall include complications associated with endoscopic necrosectomy through the 21 (+/-7) day follow-up period. Potential endoscopic complications include perforation and bleeding.

  21 +/- 7 Days

Secondary Outcomes (6)

• Effectiveness: Number of Participants With at Least 70% of Necrotic Debris Removed

  21 +/- 7 Days

• Mean Total Procedure Time to Achieve at Least 70% Reduction in Necrosis

  Completion of all necrosectomy procedures per patient

• Adequacy of Procedural Debridement: Mean Percent Necrotic Material Removed From the WOPN Cavity Per Procedure.

  This outcome was assessed at the completion each necrosectomy procedure per participant. At the completion of all necrosectomy procedures for all participants, an overall mean percent necrotic material removed from the WOPN per procedure was calculated.

• Mean Number of Necrosectomy Procedures Required Per Participant to Achieve at Least 70% Reduction in Necrosis.

  This outcome was assessed at completion of all necrosectomy procedures per participant. After completion of all necrosectomy procedures in all participants the overall mean number of procedures to achieve at least 70% reduction in necrosis was calculated.

• Mean Length of Hospital Stay Per Participant

  At patient discharge from hospital

Study Arms (1)

EndoRotor Therapy

EXPERIMENTAL

Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.

Device: EndoRotor Therapy

Interventions

EndoRotor Therapy DEVICE

To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.

EndoRotor Therapy

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are \>22; inclusive of males and females.
• Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage
• Imaging suggestive of greater than or equal to 30% necrotic material
• Walled off pancreatic necrosis size ≥6 cm and ≤22cm
• Subject can tolerate repeated endoscopic procedures
• Subject capable of giving informed consent.
• 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 through 21 (+/- 7) days, as indicated.

You may not qualify if:

• Subject unable to give informed consent.
• Subject is unwilling to return for repeated endoscopies.
• Documented Pseudoaneurysm \> 1cm within the WOPN
• Intervening gastric varices or unavoidable blood vessels within the access tract (visible using endoscopy or endoscopic ultrasound).
• Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure
• Any condition that in the opinion of the investigator would create an unsafe clinical situation that would not allow the patient to safely undergo an endoscopic procedure (lack of medical clearance).
• 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 known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.

Sponsors & Collaborators

• Interscope, Inc.: lead

Study Sites (10)

Benjamin Tharian

Little Rock, Arkansas, 72205, United States

Location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

California Pacific Medical Center - Sutter Health

San Francisco, California, 94115, United States

Location

University of Chicago Department of Medicine

Chicago, Illinois, 60637, United States

Location

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Arvin Trindade

Queens, New York, 11040, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Frankfurt Medicine

Frankfurt, 60590, Germany

Location

Interdisciplinary Clinic for Endoscopy - TU Munich

München, 81675, Germany

Location

Erasmus Medical Center

Rotterdam, 3015 CE, Netherlands

Location

Related Publications (1)

• Stassen PMC, de Jonge PJF, Bruno MJ, Koch AD, Trindade AJ, Benias PC, Sejpal DV, Siddiqui UD, Chapman CG, Villa E, Tharian B, Inamdar S, Hwang JH, Barakat MT, Andalib I, Gaidhane M, Sarkar A, Shahid H, Tyberg A, Binmoeller K, Watson RR, Nett A, Schlag C, Abdelhafez M, Friedrich-Rust M, Schlachterman A, Chiang AL, Loren D, Kowalski T, Kahaleh M. Safety and efficacy of a novel resection system for direct endoscopic necrosectomy of walled-off pancreas necrosis: a prospective, international, multicenter trial. Gastrointest Endosc. 2022 Mar;95(3):471-479. doi: 10.1016/j.gie.2021.09.025. Epub 2021 Sep 22.

  PMID: 34562471 DERIVED

MeSH Terms

Conditions

Pancreatitis; Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Results Point of Contact

• Title: Alexis James Global Director of Clinical Affairs
• Organization: Interscope, Inc.

alexis.james@interscopemed.com

508-847-9478

Study Officials

• Marco Bruno, MD PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy with walled off pancreatic necrosis (WOPN).

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 3, 2018
• Study Start: November 15, 2018
• Primary Completion: August 22, 2019
• Study Completion: August 22, 2019
• Last Updated: November 2, 2021
• Results First Posted: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); NL (1); DE (2)