Polyp Detection With The Peerscope System™

Completed · Phase 2

Conditions studied: Colon Polyps and Adenomas, Colon Cancer

In brief

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.

Key facts

Study ID

NCT01549535

Run by

PeerMedical Ltd.

People needed

197

Starts

2012-02-01

Expected to finish

2013-07-01

Last updated by the study team

2016-11-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject between the ages of 18 and 70
• The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
• Written informed consent must be available before enrollment in the trial
• For women with childbearing potential, adequate contraception

You may not qualify if…

• Patients with a history of colonic resection;
• Patients with known (or newly diagnosed) inflammatory bowel disease;
• Patients with a personal history of polyposis syndrome;
• Patients with suspected chronic stricture potentially precluding complete colonoscopy;
• Patients with diverticulitis or toxic megacolon;
• Patients with a history of radiation therapy to abdomen or pelvis;
• Patients with acute lower GI bleeding
• Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.

Where it is running

• North Shore Gasstroenterology Assoiates, P.C. — New York, New York, United States
• Southshore Gasstroenterology, P.C — New York, New York, United States
• Carmel Medical Center — Haifa, Israel
• Elisha Medical Center — Haifa, Israel
• The Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
• UMC — Utrecht, Netherlands

Full record on ClinicalTrials.gov

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