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Evaluation of Safety and Efficacy of a New Colonoscope, ProtectiScope CS, to Diagnose Large Bowel Diseases

Phase 1/Phase 2
18 Years
80 Years
Not Enrolling
Colon Cancer

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Trial Information

Evaluation of Safety and Efficacy of a New Colonoscope, ProtectiScope CS, to Diagnose Large Bowel Diseases

The ProtectiScope CS is a disposable-based colonoscope incorporating a miniature video
camera,integral light source along with single-use sleeves and application Channels.

The ProtectiScope CS is intended to provide visualization and therapeutic access to the
Lower Gastrointestinal Tract, in adult patient populations.

Inclusion Criteria:

- Subject between the ages of 18 and 80

- Subject is indicated for screening colonoscopy

- Subject is willing to sign informed consent form

Exclusion Criteria:

- Subject is suspected, based on radiographic or other clinical grounds, of
suffering from one or more of the following: full or partial colonic obstruction;
acute abdomen; gross hematochezia; severely ulcerated colon; diverticulitis;
severe diverticulosis; toxic megacolon.

- Subject has active cardiac problems and history of heart failure, severe pulmonary
diseases renal failure (creatinine >2) uncontrolled diabetes and any other illness
judged by investigator to substantiate exclusion.

- Subject has a history of significant other diseases.

- Subject has a history of psychiatric disorders which would prevent compliance
with study instructions

- For female subjects, suspicion of pregnancy

- Subject has received treatment with another investigational drug or device
within the past 30 days

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To determine the success rate in reaching within working distance of the Cecum with no complications.

Outcome Time Frame:

1 month

Safety Issue:


Principal Investigator

Ori Segol, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Carmel Medical Center


Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:




Start Date:

October 2008

Completion Date:

January 2009

Related Keywords:

  • Colon Cancer
  • colonoscopy
  • disposable
  • single use
  • Colonic Neoplasms