Effectiveness and Safety of the Endoscopic Removal of Large and Flat Colonic Polyps With LumenR RetractorTM
Condition: Colonic Adenomatous Polyps
MeSH terms: Adenomatous Polyps; Polyps; Colonic Polyps
Study type: Interventional

Summary: 
      Colorectal cancer accounted for 142,570 new cancer cases and 51,370 cancer deaths in USA in
      2010 and worldwide has become the third most common cancer and second leading cause of cancer
      related deaths. Colonic adenomatous polyps are known precursors of colorectal cancer and
      endoscopic removal of the polyps prevents development of colon cancer.

      Removal of such large polyps requires special endoscopic techniques-endoscopic mucosal
      resection (EMR) and endoscopic submucosal dissection (ESD), which are more technically
      difficult to perform, labor intensive, time consuming and carries higher risks of
      complications (bleeding, perforations, etc.). The purpose of this study is to determine the
      effectiveness and safety of the LumenR Retractor in performing EMR and ESD. It is
      hypothesized that the use of this modified colonic overtube will simplify colonoscopic
      removal of difficult polyps, decrease the time needed to complete the procedure and decrease
      the rate of complications post endoscopic removal of large and flat colonic.
    

Detailed description: 
      All patients presented for endoscopic removal of difficult colonic polyps will be eligible
      for the study based on inclusion and exclusion criteria. All procedures will be explained by
      the Investigator and all subjects undergoing treatment will review and sign the study
      Informed Consent prior to the procedure. Each subject will be randomly assigned to two
      groups, Group 1 and Group 2, and according to the assignment, the LumenR Retractor will be
      used or not during the procedure.

      Patient preparation, including intravenous sedation, will be the same for both Groups.

      Group 1: A traditional pediatric colonoscope will be advanced into the colon and endoscopic
      removal of the polyp will be performed.

      Group 2: A traditional pediatric colonoscope with a modified overtube preloaded over the
      endoscope will be advanced into the colon. After the polyp is reached, the overtube will be
      advanced forward and expanded around the polyp. Endoscopic removal of the polyp with the use
      of commercially available graspers and biopsy forceps inserted through the overtube working
      channels will be performed.

      At the conclusion of each procedure, the size of the polyp, total procedure time, amount of
      CO2 used for colonic insufflation, amount of fluid used for submucosal injection, and any
      complications, including bleeding and perforation, will be recorded. At the end of the
      procedure, if necessary, the resulting mucosal defect after lesion removal will be closed
      with endoscopic clips or endoscopic suturing device.

      After completion of procedure, all subjects will be recovered according to standard recovery
      room protocol and then discharged home or admitted to hospital if necessary. Subjects will be
      followed at 24 hours, and 10 days post treatment and any complications post endoscopic
      removal of the polyp will be recorded. At 3 months post treatment, all subjects will have
      repeat colonoscopy to evaluate post polypectomy site and remove any residual polypoid tissue
      found.
    

Intervention name(s): LumenR Retractor; Removal without overtube
Intervention type(s): Device; Device
Intervention description(s): Polyp removal using LumenR Retractor Modified overtube; Endoscopic removal of polyp without overtube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment