EndoRotor® Endoscopic Mucosal Resection System for the Colon

NCT04203667 | Completed Results DMC FDA Device

• 1 other identifier: CLIN-0001
• Study Type: interventional
• Target: 66
• Locations: 4 countries
• Sites: 11

Brief Summary

The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR. In this trial investigators will conduct a post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.

Conditions

Polyp of Colon; Endoscopic Mucosal Resection; Recurrent Colon Adenoma

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint Defined as the Ability of the EndoRotor to Resect Lesions Without Concomitant Use of Other Resection Modalities and With no Device-related Serious Adverse Events Through the 90 Day Post Procedure Follow-up Visit.

  Index Procedure through 90 Day Post Procedure Follow-up Visit

• Primary Safety Analysis Defined as the Occurrence of Serious Adverse Events Related to the EndoRotor Device as Measured From the Index Procedure Through the 90 Day Post Procedure Follow-up Visit.

  Index Procedure through 90 Day Post Procedure Follow-up Visit

Secondary Outcomes (4)

• Efficacy Defined as the Number of Participants Where EndoRotor Was Able to Resect the Entire Lesion in a Single Procedure.

  Index Procedure

• Post-resection Stenosis Defined as the Occurrence of Colon Stenosis Following the Index Procedure.

  90-day follow-up visit

• Rate of Disease Persistence Defined as Remnant Disease at the Location of the Index Resection as Determined Endoscopically by the Investigator at the 90 Day Follow-up Visit.

  90-day follow-up visit

• Histologic Assessment Defined as the the Diagnostic Value of the Specimens Collected in the EndoRotor Specimen Trap (Could a Diagnosis be Rendered).

  90-day follow-up visit

Study Arms (1)

EndoRotor Resection Arm

OTHER

All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection.

Device: EndoRotor Resection

Interventions

EndoRotor Resection DEVICE

The EndoRotor® is a powered cutting cannula for the removal of alimentary tract mucosa. Cutting is performed by aspirating tissue into a rotating cutting window. The resected tissue is immediately aspirated away from the resection site and collected in the EndoRotor Specimen Trap. The tissue can then be sent for pathological examination using standard methods. The system consists of a power console, foot control, specimen trap with pre-loaded filter and the applied part, which is the single-use catheter.

EndoRotor Resection Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged ≥18 to ≤85 years.
• At least one recurrent flat or sessile colorectal lesion measuring up to 6 cm in diameter and/or length.
• Presence of recurrent flat or sessile lesion where the EndoRotor may be used to resect recurrent neoplasia.
• Favorable anatomy that allows the investigator to access the lesion.
• Subject is able and willing to comply with site standard medical follow-up, including the 90-day follow-up visit.
• Subject has been informed of the nature of the study, agrees to participate and has signed the consent form.

You may not qualify if:

• Inability to give informed consent.
• Subject age is \<18 years of age or \>85 years of age.
• Presence of a lesion that represents cancer or has a high chance of harboring submucosal invasive cancer.
• Presence of synchronous lesions intended for resection that would require use of a concomitant resection modality
• Medical reasons the procedure cannot be performed (i.e. labile blood pressure, anticoagulation laboratory levels that are too high and risk excessive bleeding, systemic infection, etc.)
• Active antiplatelet therapy (Plavix , 325mg aspirin therapy) - patient off treatment for \< 1 week.
• Inability to undergo a procedure under propofol sedation or General Anesthesia.
• Female patients who are known to be pregnant.
• Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g., severe chronic obstructive pulmonary disease, hepatic failure, cardiac disease, autoimmune disorders or conditions of severe immunosuppression).
• Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device.
• Subject is participating in another study of a device, medication, biologic, or other agent within 90 days and could, in the opinion of the investigator, impact the results of this study.
• Subject has other medical, social or psychological problems that in the opinion of the investigator would preclude them from receiving this treatment and the procedures and participating in evaluations pre- and post-treatment.

Sponsors & Collaborators

• Interscope, Inc.: lead

Study Sites (11)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Centre Hospitalier Universitaire (CHU)

Angers, France

Location

Hopital Edouard Herriot

Lyon, 69003, France

Location

Cochin University Hospital

Paris, 75014, France

Location

Allgemeines Krankenhaus Celle

Celle, 29223, Germany

Location

Clinic and Polyclinic for Interdisciplinary Endoscopy University Hospital Hamburg Eppendorf

Hamburg, Germany

Location

Catholic Clinic Mainz

Mainz, Germany

Location

Sana Klinikum Offenbach

Offenbach, 63069, Germany

Location

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25124, Italy

Location

Università Cattolica del Sacro Cuore, Instituto di Clinica Chirurgica

Rome, 00168, Italy

Location

Humanitas Research Hospital & Humanitas University

Rozzano, 20089, Italy

Location

Related Publications (1)

• Knabe M, Maselli R, Cesbron-Metivier E, Hollerbach S, Petruzziello L, Prat F, Khara HS, Pioche M, Hartmann D, Cesaro P, Barbaro F, Berger A, Spada C, Diehl DL, May A, Ponchon T, Repici A, Costamagna G. Endoscopic powered resection device for residual colonic lesions: the first multicenter, prospective, international clinical study. Gastrointest Endosc. 2024 May;99(5):778-786. doi: 10.1016/j.gie.2023.11.050. Epub 2023 Dec 1.

  PMID: 38042207 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

COVID pandemic made follow-up at each center difficult or impossible for patients who had a 90 day follow-up from March 2020 and beyond. Most of Europe was on lockdown from this point through June 2021.

Results Point of Contact

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

alexis.james@interscopemed.com

508-847-9478

Study Officials

• Guido Costamagna, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Study Start: April 18, 2018
• Primary Completion: April 5, 2020
• Study Completion: April 5, 2020
• Last Updated: April 5, 2022
• Results First Posted: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3); FR (3); US (1); DE (4)