Trial Outcomes & Findings for PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon (NCT NCT00604162)

8 Hospital sites

Four patients withdrew before completing the study documents and were not included in the analysis.An additional 8 patients were not included in the analysis of the accuracy of polyp detection.

PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon

The number of participants that completed the capsule endoscopy procedure with video images of the entire colon that could be read by a clinician, or subsequently had a full colonoscopy with visualization by a different clinician. The number of successful procedures of each type are reported.

Since the standard colonoscopy is the "gold standard" to which the PillCam is to be compared, the number of participants with the indicated lesions identified by a trained clinician using standard colonoscopy procedures is reported here. Note that some Participants had multiple lesions and so could be included in more than one size category. Advanced adenoma is defined as 1) an adenoma 1 cm or larger or 2) an adenoma with villous features or high-grade dysplasia. All colorectal cancers were 6mm or larger.

Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Sensitivity was calculated as the percentage of participants who had positive findings on capsule endoscopy (of a specified category) among those participants who had positive findings on colonoscopy of the same category (reported in Outcome Measure 1). The false negative rate is equal to 1 - sensitivity and indicated the percentage of lesions missed by capsule endoscopy.

Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Specificity was calculated as the percentage of participants who had negative findings on capsule endoscopy (of a specified category) among participants with negative colonoscopy findings of the same category (reported in Outcome Measure 1). This corresponds to 1 - the false positive rate.

Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows: 1. poor cleansing level (Large amount of fecal residue.) 2. fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.) 3. good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.) 4. excellent cleansing level (No more than small bits of adherent feces.)