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
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.
• 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.