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PillCam Colon Capsule and CT-colonography in the Evaluation of Patients With Incomplete Conventional Colonoscopy

18 Years
75 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

PillCam Colon Capsule and CT-colonography in the Evaluation of Patients With Incomplete Conventional Colonoscopy

Inclusion Criteria:

- Subject is between the ages of 18-75 years.

- Subject is referred for colonoscopy as clinically indicated for any reason. This may
include, but not limited to, the investigation of any of the following conditions:
rectal bleeding, melena, positive stool testing for occult blood, recent change of
bowel habits, screening for colorectal cancer, colonic findings on an imaging study

- Subject in which conventional colonoscopy was incomplete

Exclusion Criteria:

- Subject has dysphagia or any swallowing disorder

- Subject has Congestive heart failure

- Subject has high degree of renal insufficiency

- Subject has had prior abdominal surgery of the gastrointestinal tract other than
uncomplicated procedures that would be unlikely to lead to bowel obstruction based on
the clinical judgment of the investigator

- Subject has a cardiac pacemaker or other implanted electromedical device.

- Subject has any allergy or other known contraindication to the medications used in
the study

- Subject is expected to undergo MRI examination within 7 days after ingestion of the

- Subject with any condition believed to have an increased risk for capsule retention
such as Crohn's disease, intestinal tumors, radiation enteritis, or NSAID

- Subject has any condition, which precludes compliance with study and/or device

- Women who are either pregnant or nursing at the time of screening, who intend to be
during the study period, or are of child bearing potential and do not practice
medically acceptable methods of contraception

- Subject suffers from life threatening conditions

- Subject currently participating in another clinical study

- Iodine contrast allergy

- Hyperthyroidism

- Inflammatory bowel disease

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Outcome Measure:

To evaluate the completeness of colonic exploration in patients with a previous incomplete conventional colonoscopy due to technical failure (not due to inadequate cleansing level).

Outcome Time Frame:

12 months

Safety Issue:



Italy: Ethics Committee

Study ID:




Start Date:

November 2011

Completion Date:

December 2012

Related Keywords:

  • Colorectal Cancer
  • colon capsule endoscopy
  • CT-colonography
  • Patients
  • incomplete colonoscopy
  • Colorectal Neoplasms