Colon Cancer Clinical Trial
Official title:
a Prospective Clinical Study to Establish the Usability of the PeerScope B System™ When Used During Standard Colonoscopy Procedure
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.
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. ;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
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