PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon (MA-53)
To see if PillCam COLON will demonstrate diagnostic yield >80% in detecting significant colonic pathologies when compared to colonoscopy in the target population.
Device: PillCam COLON
Procedure: Standard colonoscopy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Evaluation of PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon|
- Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies [ Time Frame: 1 day ] [ Designated as safety issue: No ]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.
- Number of Participants With Indicated Lesions Detected by Standard Colonoscopy [ Time Frame: 1 day ] [ Designated as safety issue: No ]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.
- Sensitivity of Capsule Endoscopy for Indicated Lesions [ Time Frame: 1 day ] [ Designated as safety issue: No ]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.
- Specificity of Capsule Endoscopy for Indicated Lesions [ Time Frame: 1 day ] [ Designated as safety issue: No ]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.
- Percent of Participants With Scoring Index 3 or 4 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows:
- poor cleansing level (Large amount of fecal residue.)
- fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.)
- good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.)
- excellent cleansing level (No more than small bits of adherent feces.)
- Number, Type and Severity of Adverse Events [ Time Frame: Within 7 days ] [ Designated as safety issue: Yes ]
- Accuracy Parameters (Sensitivity, Specificity, Negative Predicted Value, Positive Predicted Value) of Colon Capsule Endoscopy, Compared to Standard Colonoscopy [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
- Percentage of Excreted Colon Capsules [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]
- Colon Capsule Endoscopy Transit Time Per Section (Stomach, Small Bowel, Colon) [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Experimental: PillCam COLON and Colonoscopy
Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases, had capsule endoscopy with PillCam COLON after bowel preparation and before standard colonoscopy.
Device: PillCam COLON
The PillCam COLON capsule is an ingestible capsule equipped with an endoscope that has two imagers, enabling it to acquire video images from both ends. the device measures 31 by 11 mm and acquires images at a rate of 4 frames per second. Recording and downloading of data are similar those of the data for small-bowel capsule endoscopy.Procedure: Standard colonoscopy
Standard colonoscopy was the standard against which capsule endoscopy was compared,and it was performed after capsule endoscopy (after capsule excretion or at least 10 hours after capsule ingestion, whichever came first), on either the same day as ingestion or the next morning.
The development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. This is expected to improve the capability of the Given® Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease.
This study is designed to compare capsule colonoscopy and colonoscopy procedures in detecting colon abnormalities. Note that the physician performing the capsule endoscopy and reading the capsule videos and the physician performing the colonoscopy were unaware of each other's findings until completion of the examinations and reports (assessor-blind).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604162
|Clinica Universitaria de Navarra|
|St.Marks&Northwick Park hospital|
|Harrow, United Kingdom|
|Principal Investigator:||Jacques DEVIERE, M.D||Hôpital Erasme|