EndoRotor® Endoscopic Mucosal Resection System for the Colon

NCT ID: NCT04203667

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-18
• Study Completion Date: 2020-04-05

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.

Conditions

Polyp of Colon; Endoscopic Mucosal Resection; Recurrent Colon Adenoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EndoRotor Resection Arm

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.

Group Type: OTHER

EndoRotor Resection

Intervention Type: 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.

Interventions

EndoRotor Resection

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subjects aged ≥18 to ≤85 years.

2. At least one recurrent flat or sessile colorectal lesion measuring up to 6 cm in diameter and/or length.

3. Presence of recurrent flat or sessile lesion where the EndoRotor may be used to resect recurrent neoplasia.

4. Favorable anatomy that allows the investigator to access the lesion.

5. Subject is able and willing to comply with site standard medical follow-up, including the 90-day follow-up visit.

6. Subject has been informed of the nature of the study, agrees to participate and has signed the consent form.

Exclusion Criteria

1. Inability to give informed consent.

2. Subject age is <18 years of age or >85 years of age.

3. Presence of a lesion that represents cancer or has a high chance of harboring submucosal invasive cancer.

4. Presence of synchronous lesions intended for resection that would require use of a concomitant resection modality

5. 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.)

6. Active antiplatelet therapy (Plavix , 325mg aspirin therapy) - patient off treatment for < 1 week.

7. Inability to undergo a procedure under propofol sedation or General Anesthesia.

8. Female patients who are known to be pregnant.

9. 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).

10. Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device.

11. 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.

12. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Interscope, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guido Costamagna, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

Geisinger Medical Center

Danville, Pennsylvania, United States

Centre Hospitalier Universitaire (CHU)

Angers, , France

Hopital Edouard Herriot

Lyon, , France

Cochin University Hospital

Paris, , France

Allgemeines Krankenhaus Celle

Celle, , Germany

Clinic and Polyclinic for Interdisciplinary Endoscopy University Hospital Hamburg Eppendorf

Hamburg, , Germany

Catholic Clinic Mainz

Mainz, , Germany

Sana Klinikum Offenbach

Offenbach, , Germany

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, , Italy

Università Cattolica del Sacro Cuore, Instituto di Clinica Chirurgica

Rome, , Italy

Humanitas Research Hospital & Humanitas University

Rozzano, , Italy

Countries

United States; France; Germany; Italy

References

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.

Reference Type: DERIVED

PMID: 38042207 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CLIN-0001

Identifier Type: -

Identifier Source: org_study_id