Know Cancer

or
forgot password

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


N/A
18 Years
70 Years
Not Enrolling
Both
Colon Cancer, Colon Diseases, Colon Polyps, Colon Adenomas

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

6 month

Safety Issue:

No

Principal Investigator

Ian Gralnek, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ministry of Health, Israel

Authority:

Israel: Ministry of Health

Study ID:

CD-1130

NCT ID:

NCT01483040

Start Date:

September 2011

Completion Date:

November 2011

Related Keywords:

  • Colon Cancer
  • Colon Diseases
  • Colon Polyps
  • Colon Adenomas
  • wide angle view colonoscopy
  • PeerScope B System™
  • Adenoma
  • Colonic Neoplasms
  • Colonic Diseases
  • Colonic Polyps

Name

Location