Evaluation of PillCam™ Colon 2 in Visualization of the Colon

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01063231
• Date of registration: 18/10/2009
• Prospective Registration: No
• Primary sponsor: Medtronic - MITG
• Public title: Evaluation of PillCam™ Colon 2 in Visualization of the Colon
• Scientific title: Evaluation of PillCam™ Colon 2 in Visualization of the Colon
• Date of first enrolment: September 2009
• Target sample size: 119
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01063231
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belgium, France, Germany, Italy, Netherlands, Spain, Sweden

Contacts

• Name: Guido Costamagna, Prof.
• Affiliation: Ospedale Gemelli

• Name: Guido Costamagna, Prof
• Affiliation: Ospedale Gemelli

Key inclusion & exclusion criteria

Inclusion criteria:

- Subject is between the ages of 18-80

- Subject was referred to colonoscopy for at least one of the following reasons:

- Colorectal cancer screening for age =50

- Clinical symptoms such as: rectal bleeding, hematochezia, melena, positive FOBT,
recent change of bowel habits for age =50

- Positive findings in the colon (e.g. Polyp =10mm)

- Personal history of polyps that were removed at least 3 years ago (3 years and
above)

Exclusion criteria

- Subject has dysphagia or any swallowing disorder

- Subject has congestive heart failure

- Subject has high risk of renal insufficiency associated with the use of sodium
phosphate

- Subject is not eligible for colon preparation due to the presence of underlying
conditions based on the clinical judgment of the investigator

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

- 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 electro medical device.

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

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

- Subject with gastrointestinal motility disorders

- Subject has known delayed gastric emptying

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

- Women who are either pregnant at the time of screening, 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

and Large Bowel Diseases

Colonic Diseases

Intervention(s)

Device: PillCam™ (Capsule Endoscopy) Colon 2 capsule

Primary Outcome(s)

Accuracy parameters of PillCam™ COLON 2 in detecting patients with colonic polyps =6mm and =10 mm as compared to conventional colonoscopy [Time Frame: within 7 days]

Secondary Outcome(s)

Diagnostic yield of PillCam™ COLON 2 in detecting colonic lesions as compared to conventional colonoscopy [Time Frame: within 7 days]

Distribution of capsule excretion time up to 10 hours post ingestion based on Rapid videos [Time Frame: within 7 days]

Prevalence of polyps at different size categories and locations as detected by capsule and by conventional colonoscopy [Time Frame: Within 7 days]

Assessment of colon cleansing level at different colon segments for PillCam and Colonoscopy [Time Frame: within 7 days]

Capsule transit time within stomach, small bowel and colon based on Rapid videos [Time Frame: within 7 days]

RAPID reading time Number, type and severity of adverse events [Time Frame: with in 7 days]

Secondary ID(s)

MA-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors