Spots Global Cancer Trial Database for PeerScope B System™ Clinical Protocol

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Trial Identification

Brief Title: PeerScope B System™ Clinical Protocol

Official Title: a Prospective Clinical Study to Establish the Usability of the PeerScope B System™ When Used During Standard Colonoscopy Procedure

Study ID: NCT01483040

Conditions

Interventions

colonoscopy system (PeerScope B System™)

Study Description

Brief Summary: The PeerScope B System™ by PeerMedical Ltd. is intended to provide visualization (via a video monitor) and therapeutic access to the lower intestinal tract. The lower intestinal tract includes, but is not restricted to the organs, tissues and subsystems: large bowel and cecum. The device is introduced rectally, as with any standard colonoscope when indications consistent with the need for the procedure are observed in the adult patient population. The purpose of this prospective clinical study is to establish the usability of the PeerScope B System™ when used during standard colonoscopy procedure. The study population is comprised of patients indicated for colonoscopy. The primary endpoint is reaching the cecum of the colon with PeerScope B System™.Secondary endpoints: 1. The first secondary endpoint is the incidence of complications using the PeerMedical colonoscope. 2. The second secondary endpoint is successful therapeutic interventions as biopsies, polypectomies, APC etc. 3. The third secondary endpoint is the procedure time. 4. The fourth secondary endpoint is the subjective evaluation of the additional view angle by the physician. 5. The fifth secondary endpoint is patient satisfactory.

Detailed Description: Founded in 2009, PeerMedical develops colonoscopes capable of wide view angle at the press of the button. The PeerScope B System™ is an endoscopic platform that enables the physician to get a wide angle view while maintaining all of the features commonly used during Gastrointestinal (GI) procedures with very limited learning curve and in service process. The current standard devices have viewing limitations. By adding this viewing functionality, PeerMedical will potentially empower physicians to improve polyps detection and cancers within the colon.