PeerScope B System™ Clinical Protocol

Not Applicable

Completed

• Conditions: Colon Cancer; Colon Diseases; Colon Polyps; Colon Adenomas

• Registration Number: NCT01483040
• Lead Sponsor: PeerMedical Ltd.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-11-29
• Study First Posted: 2011-12-01
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-07
• Last Update Posted: 2012-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The primary endpoint is reaching the cecum of the colon with PeerScope B S	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

Trial Locations

Locations (1)

Elisha Medical Center; 🇮🇱 Haifa, Israel