PeerScope B System™ Clinical Protocol
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:
- The first secondary endpoint is the incidence of complications using the PeerMedical colonoscope.
- The second secondary endpoint is successful therapeutic interventions as biopsies, polypectomies, APC etc.
- The third secondary endpoint is the procedure time.
- The fourth secondary endpoint is the subjective evaluation of the additional view angle by the physician.
- The fifth secondary endpoint is patient satisfactory.
|Colon Cancer Colon Diseases Colon Polyps Colon Adenomas||Device: colonoscopy system (PeerScope B System™)|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||a Prospective Clinical Study to Establish the Usability of the PeerScope B System™ When Used During Standard Colonoscopy Procedure|
- The primary endpoint is reaching the cecum of the colon with PeerScope B S [ Time Frame: 6 month ]a full colonoscopy procedure is characterized by reaching an anatomical mark (cecum)at the end of the insertion phase and then the physician start the withdrawal screening phase
|Study Start Date:||September 2011|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Device: colonoscopy system (PeerScope B System™)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483040
|Elisha Medical Center|
|Principal Investigator:||Ian Gralnek, Prof.||Ministry of Health, Israel|