PeerScope B System™ Clinical Protocol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PeerMedical Ltd.
ClinicalTrials.gov Identifier:
NCT01483040
First received: November 22, 2011
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

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.

Condition Intervention
Colon Cancer
Colon Diseases
Colon Polyps
Colon Adenomas
Device: colonoscopy system (PeerScope B System™)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: a Prospective Clinical Study to Establish the Usability of the PeerScope B System™ When Used During Standard Colonoscopy Procedure

Resource links provided by NLM:


Further study details as provided by PeerMedical Ltd.:

Primary Outcome Measures:
  • The primary endpoint is reaching the cecum of the colon with PeerScope B S [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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


Enrollment: 50
Study Start Date: September 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: colonoscopy system (PeerScope B System™)
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483040

Locations
Israel
Elisha Medical Center
Haifa, Israel
Sponsors and Collaborators
PeerMedical Ltd.
Investigators
Principal Investigator: Ian Gralnek, Prof. Ministry of Health, Israel
  More Information

No publications provided

Responsible Party: PeerMedical Ltd.
ClinicalTrials.gov Identifier: NCT01483040     History of Changes
Other Study ID Numbers: CD-1130
Study First Received: November 22, 2011
Last Updated: November 7, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by PeerMedical Ltd.:
wide angle view colonoscopy
PeerScope B System™

Additional relevant MeSH terms:
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 16, 2014