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

NCT01233310 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 26

Last updated 2019-07-31

No results posted yet for this study

Summary

Study Hypothesis:

It is estimated that by re-programming some of the PillCam COLON2 system parameters it can serve as tool for visualizing both small bowel and colon. As such, the system may be utilized in CD patients for monitoring mucosal healing.

Primary objectives:

To evaluate two different video output methods in the visualization of the SB and colon in CD patients

Secondary objectives:

* Evaluate the level of agreement between PillCam system and ileocolonoscopy on the assessment of CD findings.
* Evaluate the effectiveness of PillCam regimen in CD patients

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

Conditions

  • Crohn Disease

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Yaron Niv, Professor · Belinson medical center

  • Abraham Eliakim, Professor · Rambam Health Care center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01233310 on ClinicalTrials.gov