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EndoRotor® Endoscopic Mucosal Resection System for the Colon

Primary Purpose

Polyp of Colon, Endoscopic Mucosal Resection, Recurrent Colon Adenoma

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

EndoRotor Resection

About this trial

This is an interventional treatment trial for Polyp of Colon

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Geisinger Medical Center
Centre Hospitalier Universitaire (CHU)
Hopital Edouard Herriot
Cochin University Hospital
Allgemeines Krankenhaus Celle
Clinic and Polyclinic for Interdisciplinary Endoscopy University Hospital Hamburg Eppendorf
Catholic Clinic Mainz
Sana Klinikum Offenbach
Fondazione Poliambulanza Istituto Ospedaliero
Università Cattolica del Sacro Cuore, Instituto di Clinica Chirurgica
Humanitas Research Hospital & Humanitas University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

EndoRotor Resection Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

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

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.

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

Full Information

NCT ID

NCT04203667

First Posted

December 16, 2019

Last Updated

April 1, 2022

Sponsor

Interscope, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04203667

Brief Title

EndoRotor® Endoscopic Mucosal Resection System for the Colon

Official Title

Prospective, Multicenter Study for the Evaluation of Safety and Performance of the Interscope EndoRotor Endoscopic Mucosal Resection System for the Removal of Alimentary Tract Mucosa in the Colon

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

April 18, 2018 (Actual)

Primary Completion Date

April 5, 2020 (Actual)

Study Completion Date

April 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Interscope, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

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

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.

Detailed Description

Although the majority of polyps are non-malignant, it is known that the risk of malignancy increases with polyp size, with polyps < 10 mm having < 1% risk of cancer, polyps of 10 mm having a 10% risk of cancer and polyps of 20 mm having a greater than 10% risk of cancer. It is also understood that a polyp of < 1 cm takes approximately 10 years to transform into invasive colorectal carcinoma. Therefore, adenomas greater than 5 mm are normally treated. Polyps with tethered bases resulting from scarring are often the most challenging to resect endoscopically. The scarring can be caused by previous attempts at resection, previous deep biopsies, or tattoos placed too closely. These polyps often do not lift and can be impossible to snare even when stiff snares are used. Endoscopic submucosal dissection (ESD) and knife-assisted resection (KAR) are techniques that have been shown effective in the management of scarred polyps, however these techniques have not been widely adopted in the West. Argon plasma coagulation has been more commonly used to ablate adenomatous tissue in scarred polyps but this technique does not allow for the histological assessment of the scarred polyp and is less effective than ESD. The EndoRotor provides a technique whereby the lesion can be effectively removed without adjunct procedures with collection of tissue for histological assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polyp of Colon, Endoscopic Mucosal Resection, Recurrent Colon Adenoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EndoRotor Resection Arm

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

EndoRotor Resection

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

Index Procedure through 90 Day Post Procedure Follow-up Visit

Title

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.

Time Frame

Index Procedure through 90 Day Post Procedure Follow-up Visit

Secondary Outcome Measure Information:

Title

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

Time Frame

Index Procedure

Title

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

Time Frame

90-day follow-up visit

Title

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.

Time Frame

90-day follow-up visit

Title

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

Time Frame

90-day follow-up visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guido Costamagna, MD

Organizational Affiliation

Principal Investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

Geisinger Medical Center

City

Danville

State/Province

Pennsylvania

ZIP/Postal Code

17822

Country

United States

Facility Name

Centre Hospitalier Universitaire (CHU)

City

Angers

Country

France

Facility Name

Hopital Edouard Herriot

City

Lyon

ZIP/Postal Code

69003

Country

France

Facility Name

Cochin University Hospital

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Allgemeines Krankenhaus Celle

City

Celle

ZIP/Postal Code

29223

Country

Germany

Facility Name

Clinic and Polyclinic for Interdisciplinary Endoscopy University Hospital Hamburg Eppendorf

City

Hamburg

Country

Germany

Facility Name

Catholic Clinic Mainz

City

Mainz

Country

Germany

Facility Name

Sana Klinikum Offenbach

City

Offenbach

ZIP/Postal Code

63069

Country

Germany

Facility Name

Fondazione Poliambulanza Istituto Ospedaliero

City

Brescia

ZIP/Postal Code

25124

Country

Italy

Facility Name

Università Cattolica del Sacro Cuore, Instituto di Clinica Chirurgica

City

Rome

ZIP/Postal Code

00168

Country

Italy

Facility Name

Humanitas Research Hospital & Humanitas University

City

Rozzano

ZIP/Postal Code

20089

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

EndoRotor® Endoscopic Mucosal Resection System for the Colon

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