MedTrace Logo

Polyp Detection With The Peerscope System™

NCT01549535 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2016-11-25

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Colonoscopy done with:PeerMedical System and Olympus/Pentax/Fuji colonoscopy system

endoscopic diagnosis, treatment and video observation of the digestive tract, endoscopy and endoscopic treatment within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) of adults patients

Sponsors & Collaborators

  • PeerMedical Ltd.

    lead INDUSTRY

Principal Investigators

  • Ian Gralnek, Prof. · Rambam Health Care Campus

  • Peter Siersema, Prof. · UMC Utrecht

  • Erwin Santo, Prof. · The Tel Aviv Sourasky Medical Center

  • Ori Segol, Dr. · Carmel Medical Center

  • Alan Sloyer, Dr. · North Shore Gastroenterology Associates, P.C.

  • Jay S. Fenster, Dr. · Southshore Gasstroenterology, P.C

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-03-31
Completion
2013-07-31

Countries

  • United States
  • Israel
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01549535 on ClinicalTrials.gov