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

NCT ID: NCT01233310

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-04-30

Brief 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

Detailed Description

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 the overall assessment in the following segments:

1. Rectum

2. Left colon (including sigmoid)

3. Transverse colon

4. Right colon

5. Terminal ileum

3. Cleansing level for the ileocolonoscopy procedure will be assessed at each site

4. From each capsule endoscopy procedure two RAPID video versions will be generated and segmented into segments

5. A committee composed of the study investigators will review all the RAPID video segments and document their findings according to the parameters defined in the SES-CD, Lewis and CECDAI scoring systems and an overall assessment

6. The parameters for each segment per each of the two RAPID movies will be compared and the preferable video setup will be chosen

7. Final RAPID and colonoscopy movies will be de-identified in regards to patient and site identity

8. The preferable full RAPID version will be reviewed by investigators which will document their findings according to the parameters defined in the SES-CD scoring system and overall assessment

9. cleansing level for the capsule procedure will be assess

The above evaluations per each subject will be within 24 from end of rocedure.

Conditions

Crohn Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yaron Niv, Professor

Role: PRINCIPAL_INVESTIGATOR

Belinson medical center

Abraham Eliakim, Professor

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care center

Locations

Rambam Health Care center

Haifa, , Israel

Bikur Holim medical center

Jerusalem, , Israel

Belinson medical center

Petah Tikva, , Israel

Asaf Harofe medical center

Zrifin, , Israel

Countries

Israel

Other Identifiers

RD-302

Identifier Type: -

Identifier Source: org_study_id