Clinical Trial: Polyp Detection With The Peerscope System™

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Polyp Detection With The Peerscope System™: A Randomized Tandem Colonoscopy Study

Brief Summary:

The PeerScope System consists of Peer Medical camera heads, endoscopes, video system, light source and other ancillary equipment. The system is intended for endoscopic diagnosis, treatment and video observation of the digestive tract. The PeerScope system model B is indicated for use for endoscopy and endoscopic treatment within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) of adults patients.

Objective:To compare the additional diagnostic yield obtained by using the PeerScope System™ extended view vs. the diagnostic yield obtained by the Standard view colonoscopy.

In addition, time measurements including time to cecum, time for withdrawal and overall procedure time will be analyzed and reported for each group.


Detailed Summary:

Design:

Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomized to one of two groups. Each enrolled subject will undergo two "back-to-back" procedures.

Subjects in Group A (study group) will undergo a Standard view colonoscopy followed immediately by a PeerScope System™ extended view colonoscopy. Subjects in Group B (control group) will undergo a PeerScope System™ extended view colonoscopy followed immediately by a Standard view colonoscopy.

Results from the two groups will be analyzed and compared, with primary outcome measures being detection rates for total polyps and detection rates for adenomas. Secondary outcome measures will include withdrawal time, total procedure time and characteristics of polyps detected, including size and histological results.

Subjects will be followed through a 24 hour and a 7 days telephone interview for analysis of unexpected adverse events. Clinical results will be analyzed using various statistical measures of significance.

Study Design:

Multi-center study with up to 196 patients. No. of Patients:

Up to 196 treated patients will be enrolled into the study. Primary Performance Endpoint:

  • Standard view colonoscopy adenoma overall detection rate compared to the extended view overall adenoma detection rate using the PeerScope System™
  • Standard view colonoscopy overall polyp detection rate compared to the extended view overall polyp detec
    Sponsor: PeerMedical Ltd.

    Current Primary Outcome: polyp detection rate [ Time Frame: 1 year ]

    Sample size calculation is based on detecting a difference in the adenoma overall detection rate and the overall polyp detection rate using the PeerScope System™ extended view as compared to Standard view colonoscopy.

    Total sample size will be 196 patients. Each patient will undergo the procedure by the two devices: PeerScope System™ extended view and Standard view colonoscopy. The rational for this sample size is based on detecting a rate difference of 20% between the study devices.



    Original Primary Outcome:

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: PeerMedical Ltd.

    Dates:
    Date Received: February 13, 2012
    Date Started: February 2012
    Date Completion:
    Last Updated: November 22, 2016
    Last Verified: November 2016