PeerScope B System™ Clinical Protocol

PeerMedical

Status

Completed

Conditions

Colon Polyps

Colon Diseases

Colon Adenomas

Colon Cancer

Treatments

Device: colonoscopy system (PeerScope B System™)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01483040

CD-1130

Details and patient eligibility

About

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:

The first secondary endpoint is the incidence of complications using the PeerMedical colonoscope.
The second secondary endpoint is successful therapeutic interventions as biopsies, polypectomies, APC etc.
The third secondary endpoint is the procedure time.
The fourth secondary endpoint is the subjective evaluation of the additional view angle by the physician.
The fifth secondary endpoint is patient satisfactory.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.