EndoRotor® Endoscopic Mucosal Resection System for the Colon

Completed · Not applicable

Conditions studied: Polyp of Colon, Endoscopic Mucosal Resection, Recurrent Colon Adenoma

In brief

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.

Key facts

Study ID: NCT04203667
Run by: Interscope, Inc.
People needed: 66
Starts: 2018-04-18
Expected to finish: 2020-04-05
Last updated by the study team: 2022-04-05

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.