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:

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.

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Key information

Conditions

Colon Cancer Colon Adenomas Colon Diseases Colon Polyps Colonic Diseases Colonic Neoplasms Colonic Polyps Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elisha Medical Center

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Patients with a history of colonic resection;
Patients with 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 who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.

Treatment and study plan

colonoscopy system (PeerScope B System™)

Device

Cancer of the colon and rectum is second only to lung cancer as the leading cause of cancer-related deaths in the United States.Each year, about 1.23 million new cases of bowel cancer are diagnosed worldwide, 333,000 in Europe alone. Colorectal cancer almost always starts in a benign growth called a polyp. Polyps originate in the inner lining of the colon, where they may be visible in a screening test known as colonoscopy. Recent research has shown that appropriate screening and treatment can alleviate much of the suffering associated with colorectal cancer and reduce the number of deaths caused by this malignancy

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

PeerMedical Ltd.

Industry

Registry information

Official study title

a Prospective Clinical Study to Establish the Usability of the PeerScope B System™ When Used During Standard Colonoscopy Procedure

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Dec 1, 2011
Registry last updated: Nov 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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