EndoRotor® Endoscopic Mucosal Resection System for the Colon
Condition: Polyp of Colon; Endoscopic Mucosal Resection; Recurrent Colon Adenoma
MeSH terms: Adenoma; Colonic Polyps
Study type: Interventional

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.
    

Intervention name(s): EndoRotor Resection
Intervention type(s): Device
Intervention description(s): 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 model: Single Group Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment