Evaluation of Small Bowel Colon Capsule for Bowel Visualization in Crohn's Disease Patients

Launched by MEDTRONIC - MITG · Nov 2, 2010

Keywords

ClinConnect Summary

Study design: Multi-center, prospective study Number of subjects: Up to 30 study duration: up to 18 months Subject population: Subjects with moderate to severe Crohn's disease demonstrating colon involvement who are indicated to undergo standard ileocolonoscopy as part of their disease management

Study Design:

1. Each patient will undergo PillCam, procedure followed by conventional ileocolonoscopy procedure with intubation of the terminal ileum
2. During the ileocolonoscopy procedure, the colonoscopist will document his findings according to the parameters defined in the SES-CD score and ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient is 18 years of age and above
• • Patient with a diagnosis of ileocolonic or colonic Crohn's Disease documented by endoscopical, histopathological and/or radiological parameters
• • Patients' CDAI \>150.
• • Patient is clinically indicated to undergo ileocolonoscopy for assessment of Crohn's disease
• • Proven patency by Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 3 months prior to enrollment
• • Patient is able and agrees to sign the Informed Consent Form
• Exclusion Criteria:
• • Patient has dysphagia
• • Patient has congestive heart failure
• • Patient has renal insufficiency
• • Patient has cirrhosis
• • Patient is known or is suspected to suffer from intestinal obstruction
• • Patient has known previous stricture/obstruction of the SB or colon
• • Patient has taken NSAID medications less than one month before enrollment
• • Patient suffers from hypertension and is taking one or more of the following medications used for control of hypertension: diuretics, ACE inhibitors, Angiotensin II blockers
• • Chronic use of laxatives
• • Patient has a cardiac pacemakers or other implanted electro medical devices.
• • 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.
• • Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule.
• • Patient 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.
• • Patient has any condition, which precludes compliance with study and/or device instructions.
• • Patient suffers from life threatening conditions
• • Patient is currently participating in another clinical study
• • Patient has known slow gastric emptying time
• • Patient is allergic or contraindicated to any of the study medications