N/A
N=51
Evaluation of PillCam™ Colon 2 in Visualization of the Colon
Colonic Diseases · Bowel Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01087528 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: Accuracy of Detection in Patients With Colonic Polyps - Sensitivity — 89; 100 percentage of sensiivity
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PillCam™ (Capsule Endoscopy) Colon 2 capsule (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Detection in Patients With Colonic Polyps - Sensitivity |
89; 100 | — |
| PRIMARY Accuracy of Detection in Patients With Colonic Polyps - Specificity |
43; 66 | — |
| SECONDARY Diagnostic Yield of PillCam™ COLON 2 in Detecting Colonic Lesions |
83; 61; 4.5; 9; 4.5; 0 | — |
| SECONDARY Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) |
61; 86; 43; 92; 83; 86 | — |
| SECONDARY Capsule Excretion Time |
8; 13; 8; 21 | — |
Summary
To evaluate the performance of PillCam COLON 2 in regards to detection of patients with polyps where colonoscopy is considered as the gold standard reference.
Eligibility Criteria
Inclusion criteria
- Subject is between the ages of 18-70
- Subject was referred to colonoscopy for at least one of the following reasons:
- Colorectal cancer screening for age ≥60
- 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 significant polyps( ≥6mm )that were removed at least 3 years ago (3 years and above)
Exclusion criteria
- Age > 70 years
- Subject has dysphagia or any swallowing disorder
- Subject has congestive heart failure
- Subject has known renal disease
- 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>70
Data sourced from ClinicalTrials.gov (NCT01087528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.