Clinical trial NCT04203667: 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
Overall status: COMPLETED
Phase: NA
Conditions: Polyp of Colon
Endoscopic Mucosal Resection
Recurrent Colon Adenoma
Lead sponsor: Interscope, Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-18
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: Index Procedure through 90 Day Post Procedure Follow-up Visit
measure: 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.
timeFrame: Index Procedure through 90 Day Post Procedure Follow-up Visit
Secondary outcomes:
measure: Efficacy Defined as the Number of Participants Where EndoRotor Was Able to Resect the Entire Lesion in a Single Procedure.
timeFrame: Index Procedure
measure: Post-resection Stenosis Defined as the Occurrence of Colon Stenosis Following the Index Procedure.
timeFrame: 90-day follow-up visit
measure: 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.
timeFrame: 90-day follow-up visit
measure: Histologic Assessment Defined as the the Diagnostic Value of the Specimens Collected in the EndoRotor Specimen Trap (Could a Diagnosis be Rendered).
timeFrame: 90-day follow-up visit
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Angers
country: France
facility: Centre Hospitalier Universitaire (CHU)
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Paris
country: France
facility: Cochin University Hospital
city: Celle
country: Germany
facility: Allgemeines Krankenhaus Celle
city: Hamburg
country: Germany
facility: Clinic and Polyclinic for Interdisciplinary Endoscopy University Hospital Hamburg Eppendorf
city: Mainz
country: Germany
facility: Catholic Clinic Mainz
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto Ospedaliero
city: Rome
country: Italy
facility: Università Cattolica del Sacro Cuore, Instituto di Clinica Chirurgica
city: Rozzano
country: Italy
facility: Humanitas Research Hospital & Humanitas University
Study officials:
affiliation: Principal Investigator
name: Guido Costamagna, MD
role: PRINCIPAL_INVESTIGATOR
References: