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

NCT01233310 | Completed

• 1 other identifier: RD-302
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 4

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

Conditions

Crohn Disease

Keywords

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Agreement level between two PillCam videos, simulating different proposed system setups, on the severity and extent of CD lesions,up to 24 months

  up to 24 months

Secondary Outcomes (5)

• Agreement level between PillCam and conventional ileocolonoscopy on the severity and extent of CD lesions, at colon and terminal ileum, based on the SES-CD score parameters and an overall assessment per each segment, up to 24 months

  up to 24 months

• Capsule transit time statistics within stomach, small bowel and colon segments,up to 24 months

  up to 24 months

• Capsule excretion time statistics, up to 24 months

  up to 24 months

• Assessment of colon and SB cleansing level at different colon and SB,up to 24 months

  up to 24 months

• Number, type and severity of adverse events, up to 24 months

  up to 24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Crohn's disease clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (4)

Rambam Health Care center

Haifa, Israel

Location

Bikur Holim medical center

Jerusalem, Israel

Location

Belinson medical center

Petah Tikva, Israel

Location

Asaf Harofe medical center

Zrifin, Israel

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Yaron Niv, Professor

  Belinson medical center

  PRINCIPAL INVESTIGATOR

• Abraham Eliakim, Professor

  Rambam Health Care center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: November 3, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 31, 2019

Record last verified: 2012-08

Locations

IL (4)