Colonic Diseases Clinical Trial
Official title:
Evaluation of PillCam™ Colon 2 in Visualization of the Colon
NCT number | NCT01063231 |
Other study ID # | MA-201 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | September 2009 |
Est. completion date | October 2010 |
Verified date | November 2010 |
Source | Medtronic - MITG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Evaluate accuracy of PCCE-2 in detecting patients with colonic polyps as compared to conventional colonoscopy.
Status | Completed |
Enrollment | 119 |
Est. completion date | October 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Hospital Erasme - Gastro-Enterologie | Brussels | |
France | Chef de Service dHepato-Gastro-Enterologie et dAssistance Nutritionnelle CHU Nantes | Nantes | |
France | CHU Nancy | Vandoeuvre Cedex | |
Germany | Evangelisches Krankenhaus | Dusseldorf | |
Italy | Ospedale Gemelli,ENDOSCOPIA DIGESTIVA | Roma | |
Netherlands | Academic Medical Center University of Amsterdam | Amsterdam | |
Spain | Clinica Universitaria de Navarra | Pamplona | |
Sweden | Malmo University Hospital | Malmo |
Lead Sponsor | Collaborator |
---|---|
Medtronic - MITG |
Belgium, France, Germany, Italy, Netherlands, Spain, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy parameters of PillCam™ COLON 2 in detecting patients with colonic polyps =6mm and =10 mm as compared to conventional colonoscopy | within 7 days | ||
Secondary | Diagnostic yield of PillCam™ COLON 2 in detecting colonic lesions as compared to conventional colonoscopy | within 7 days | ||
Secondary | Assessment of colon cleansing level at different colon segments for PillCam and Colonoscopy | within 7 days | ||
Secondary | Distribution of capsule excretion time up to 10 hours post ingestion based on Rapid videos | within 7 days | ||
Secondary | Capsule transit time within stomach, small bowel and colon based on Rapid videos | within 7 days | ||
Secondary | Prevalence of polyps at different size categories and locations as detected by capsule and by conventional colonoscopy | Within 7 days | ||
Secondary | RAPID reading time Number, type and severity of adverse events | with in 7 days |
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